1,557 results on '"Khouri, Issa"'
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2. Liver elastography for risk-assessment of liver toxicity and risk factors for Sinusoidal obstruction syndrome in patients with acute lymphoblastic leukemia receiving inotuzumab ozogamicin
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Senapati, Jayastu, Jabbour, Elias, Short, Nicholas J., Jain, Nitin, Haddad, Fadi, Bathala, Tharakeswara, Kovalenko, Iuliia, Bidikian, Aram, Ravandi, Farhad, Khouri, Issa, Kadia, Tapan M., Garris, Rebecca, Montalban Bravo, Guillermo, Chien, Kelly, Shpall, Elizabeth, Kebriaei, Partow, and Kantarjian, Hagop M.
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- 2024
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3. Results of salvage therapy with mini-hyper-CVD and inotuzumab ozogamicin with or without blinatumomab in pre-B acute lymphoblastic leukemia
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Kantarjian, Hagop, Haddad, Fadi G, Jain, Nitin, Sasaki, Koji, Short, Nicholas J, Loghavi, Sanam, Kanagal-Shamanna, Rashmi, Jorgensen, Jeffrey, Khouri, Issa, Kebriaei, Partow, Alvarado, Yesid, Kadia, Tapan, Paul, Shilpa, Garcia-Manero, Guillermo, Dabaja, Bouthaina, Yilmaz, Musa, Jacob, Jovitta, Garris, Rebecca, O’Brien, Susan, Ravandi, Farhad, and Jabbour, Elias
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Clinical Research ,Rare Diseases ,Stem Cell Research - Nonembryonic - Human ,Pediatric Cancer ,Stem Cell Research ,Hematology ,Childhood Leukemia ,Cancer ,Pediatric ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Adult ,Humans ,Antibodies ,Bispecific ,Cardiovascular Diseases ,Inotuzumab Ozogamicin ,Methotrexate ,Precursor B-Cell Lymphoblastic Leukemia-Lymphoma ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Salvage Therapy ,Blinatumomab ,Chemo-immunotherapy ,Inotuzumab ,Outcome ,Philadelphia-negative ALL ,Salvage ,Cardiorespiratory Medicine and Haematology ,Cardiovascular medicine and haematology ,Oncology and carcinogenesis - Abstract
BackgroundHistorically, adults with relapsed-refractory acute lymphoblastic leukemia (ALL) experienced poor outcomes with intensive chemotherapy. This mature analysis explores the benefit of the addition of sequential blinatumomab to low-intensity mini-Hyper-CVD chemotherapy with inotuzumab ozogamicin in this setting.MethodsMini-Hyper-CVD (cyclophosphamide and dexamethasone at 50% dose reduction, no anthracycline, methotrexate at 75% dose reduction, cytarabine at 83% dose reduction) was combined with inotuzumab during the first 4 courses. From Patient #68 and onwards, inotuzumab was given in reduced and fractionated doses, and blinatumomab was added sequentially for 4 courses. Maintenance therapy with prednisone, vincristine, 6-mercaptopurine and methotrexate was given for 12 courses, and blinatumomab for 4 additional courses.ResultsAmong 110 patients (median age, 37 years) treated, 91 (83%) responded (complete response, 69 patients, 63%). Measurable residual disease negativity was documented in 75 patients (82% of responders). Fifty-three patients (48%) received allogeneic stem cell transplantation (SCT). Hepatic sinusoidal obstruction syndrome occurred in 9/67 patients (13%) on the original inotuzumab schedule and in 1/43 (2%) on the modified schedule. With a median follow-up of 48 months, the median overall survival (OS) was 17 months, and the 3 year OS was 40%. The 3 year OS was 34% with mini-Hyper-CVD plus inotuzumab and 52% with additional blinatumomab (P = 0.16). By landmark analysis at 4 months, the 3 year OS was 54%, similar between patients who did or did not receive allogeneic SCT.ConclusionLow-intensity mini-Hyper-CVD plus inotuzumab with or without blinatumomab showed efficacy in patients with relapsed-refractory ALL, with better survival after the addition of blinatumomab. Trial registration The trial was registered on clinicaltrials.gov with the identifier NCT01371630.
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- 2023
4. Clinical relevance of MYC/BCL2 expression and cell of origin in patients with diffuse large b-cell lymphoma treated with autologous transplant
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Al-Juhaishi, Taha, Wang, Yingjun, Milton, Denái R., Xu-Monette, Zijun Y., Jabbour, Elias, Daher, May, Im, Jin S., Bashir, Qaiser, Iyer, Swaminathan P., Marin, David, Olson, Amanda L., Popat, Uday, Qazilbash, Muzaffar, Rondon, Gabriela, Gulbis, Alison M., Champlin, Richard E., Young, Ken H., and Khouri, Issa F.
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- 2023
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5. Incidence and risk factors of early onset VOD/SOS differ in younger vs older adults after stem cell transplantation
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Marcoux, Curtis, Saliba, Rima M., Wallis, Whitney, Khazal, Sajad, Ragoonanan, Dristhi, Rondon, Gabriela, Tewari, Priti, Popat, Uday, Oran, Betul, Olson, Amanda, Bashir, Qaiser, Qazilbash, Muzaffar, Alousi, Amin, Hosing, Chitra, Nieto, Yago, Alatrash, Gheath, Marin, David, Rezvani, Katayoun, Khouri, Issa, Srour, Samer, Champlin, Richard, Shpall, Elizabeth, and Kebriaei, Partow
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- 2024
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6. Bone Marrow versus Peripheral Blood Grafts for Haploidentical Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide.
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Mehta, Rohtesh, Saliba, Rima, Alsfeld, Leonard, Jorgensen, Jeffrey, Wang, Sa, Anderlini, Paolo, Al-Atrash, Gheath, Bashir, Qaiser, Ciurea, Stefan, Hosing, Chitra, Im, Jin, Kebriaei, Partow, Khouri, Issa, Marin, David, Nieto, Yago, Olson, Amanda, Oran, Betul, Popat, Uday, Qazilbash, Muzaffar, Ramdial, Jeremy, Rondon, Gabriela, Saini, Neeraj, Srour, Samer, Rezvani, Katayoun, Shpall, Elizabeth, Champlin, Richard, and Alousi, Amin
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Bone marrow ,Chronic GVHD ,Haploidentical ,PTCy ,Peripheral blood ,Steroid-refractory GVHD ,Adolescent ,Bone Marrow ,COVID-19 ,Cyclophosphamide ,Hematopoietic Stem Cell Transplantation ,Humans ,Middle Aged ,SARS-CoV-2 - Abstract
In the coronavirus disease 19 (COVID-19) pandemic era, the number of haploidentical hematopoietic cell transplantations (HCTs) with peripheral blood (PB) grafts increased significantly compared with HCTs with bone marrow (BM) grafts, which may be associated with adverse outcomes. We compared outcomes of HCT in BM graft and PB graft recipients age ≥18 years with hematologic malignancies who underwent T cell- replete haploidentical HCT and received graft-versus-host disease (GVHD) prophylaxis with post-transplantation cyclophosphamide, tacrolimus, and mycophenolate mofetil. Among the 264 patients, 180 (68%) received a BM graft and 84 (32%) received a PB graft. The median patient age was 50 years in both groups. The majority (n = 199; 75%) received reduced-intensity conditioning. The rate of acute leukemia or myelodysplastic syndrome was higher in the BM graft recipients compared with the PB graft recipients (85% [n = 152] versus 55% [n = 46]; P < .01). The median times to neutrophil and platelet engraftment and the incidence of grade II-IV and grade III-IV acute GVHD (aGVHD) were comparable in the 2 groups. Among the patients with grade II-IV aGVHD, the rate of steroid-refractory aGVHD was 9% (95% confidence interval [CI], 5% to 18%) in the BM group versus 32% (95% CI, 19% to 54%) in the PB group (hazard ratio [HR], 3.7, 95% CI, 1.5 to 9.3; P = .006). At 1 year post-HCT, the rate of chronic GVHD (cGVHD) was 8% (95% CI, 4% to 13%) in the BM group versus 22% (95% CI, 14% to 36%) in the PB group (HR, 3.0; 95% CI, 1.4-6.6; P = .005), and the rate of systemic therapy-requiring cGVHD was 2.5% (95% CI, 1% to 7%) versus 14% (95% CI, 7% to 27%), respectively (HR, 5.6; 95% CI, 1.7 to 18; P = .004). The PB group had a significantly higher risk of bacterial and viral infections, with no appreciable advantage in the duration of hospitalization, immune reconstitution, relapse, nonrelapse mortality, or survival. Our data suggest a benefit of the use of BM grafts over PB grafts for haplo-HCT.
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- 2021
7. Myeloablative fractionated busulfan for allogeneic stem cell transplant in older patients or patients with comorbidities
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Popat, Uday R., Pasvolsky, Oren, Bassett Jr., Roland, Mehta, Rohtesh S., Olson, Amanda, Chen, Julianne, Alousi, Amin M., Al-Atrash, Gheath, Bashir, Qaiser, Gulbis, Alison M., Hosing, Chitra M., Im, Jin S., Kebriaei, Partow, Khouri, Issa, Marin, David, Nieto, Yago, Oran, Betul, Saini, Neeraj, Shigle, Terri Lynn, Srour, Samer A., Ramdial, Jeremy L., Rezvani, Katayoun, Qazilbash, Muzaffar H., Andersson, Borje S., Champlin, Richard E., and Shpall, Elizabeth J.
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- 2023
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8. Impact of graft composition on outcomes of haploidentical bone marrow stem cell transplantation
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Saliba, Rima M, Veltri, Lauren, Rondon, Gabriela, Chen, Julianne, Al-Atrash, Gheath, Alousi, Amin, Martinez, Charles, Augustine, LaJerald, Hosing, Chitra M, Oran, Betul, Rezvani, Katayoun, Shpall, Elizabeth J, Kebriaei, Partow, Khouri, Issa F, Popat, Uday, Champlin, Richard E, and Ciurea, Stefan O
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Bone Marrow ,Bone Marrow Transplantation ,Cyclophosphamide ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Stem Cell Transplantation ,Transplantation Conditioning ,Immunology - Published
- 2021
9. Optimizing the Conditioning Regimen for Hematopoietic Cell Transplant in Myelofibrosis: Long-Term Results of a Prospective Phase II Clinical Trial
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Popat, Uday, Mehta, Rohtesh S, Bassett, Roland, Kongtim, Piyanuch, Chen, Julianne, Alousi, Amin M, Anderlini, Paolo, Ciurea, Stefan, Hosing, Chitra, Jones, Roy, Kebriaei, Partow, Khouri, Issa, Lindsay, Richard, Nieto, Yago, Olson, Amanda, Oran, Betul, Qazilbash, Muzaffar H, Rondon, Gabriela, Shpall, Elizabeth J, Verstovsek, Srdan, Andersson, Borje S, and Champlin, Richard E
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Oncology and Carcinogenesis ,Stem Cell Research ,Cancer ,Clinical Research ,Clinical Trials and Supportive Activities ,Transplantation ,Stem Cell Research - Nonembryonic - Human ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Aged ,Busulfan ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Middle Aged ,Neoplasm Recurrence ,Local ,Primary Myelofibrosis ,Prospective Studies ,Transplantation Conditioning ,Vidarabine ,Myelofibrosis ,myeloablative ,reduced intensity ,stem cell transplant ,Immunology ,Cardiovascular medicine and haematology - Abstract
Optimal conditioning regimens for older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplant are not known. Likewise, the role of dose intensity is not clear. We conducted a nonrandomized, prospective, phase II trial using low-dose, later escalated to high-dose (myeloablative conditioning), busulfan with fludarabine (Bu-Flu) in myelofibrosis patients up to age 74 years. The first 15 patients received i.v. busulfan 130 mg/m2/day on days -3 and -2 ("low dose"); 31 patients received high-dose conditioning, either 100 mg/m2/day (days -5 to -2; n = 4) or pharmacokinetic-guided area under the curve of 4000 μmol/min (days -5 to -2; n = 27). The primary endpoint was day 100 nonrelapse mortality (NRM). Median age was 58 years (interquartile range [IQR], 53-63). Dynamic international prognostic scoring system-plus was intermediate (n = 28) or high (n = 18). Donors were related (n = 19) or unrelated (n = 27). Cumulative incidence of NRM was 9.7% (95% confidence interval [CI], 0-20.3) at day 100 and at 3 years in the high-dose group and 0% in the low-dose group at day 100, which increased to 20% (95% CI, 0-41.9) at 3 years. With a median follow-up of 5.1 years (IQR, 3.8-6), 3-year relapse was 32.3% (95% CI, 15.4-49.1) in high dose versus 53.3% (95% CI, 26.6-80.1) in low dose. Event-free survival was 58% (95% CI, 43-78) versus 27% (95% CI, 12-62), and overall survival was 74% (95% CI, 60-91) versus 60% (95% CI, 40-91). In multivariate analysis, high-dose busulfan had a trend toward lower relapse (hazard ratio, .44; 95% CI, .18-1.07; P = .07), with no impact on NRM. Intensifying the Bu-Flu regimen using pharmacokinetic-monitoring appears to be promising in reducing relapse without increasing NRM.
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- 2020
10. Idiopathic refractory ascites after allogeneic stem cell transplantation: a previously unrecognized entity.
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Varma, Ankur, Abraham, Susan, Mehta, Rohtesh, Saini, Neeraj, Honhar, Medhavi, Rashid, Munazza, Chen, Julianne, Srour, Samer, Bashir, Qaiser, Rondon, Gabriela, Oran, Betul, Hosing, Chitra, Nieto, Yago, Kebriaei, Partow, Alousi, Amin, Ahmed, Sairah, Marin, David, Khouri, Issa, Ciurea, Stefan, Qazilbash, Muzaffar, Rezvani, Katy, Anderlini, Paolo, Andersson, Borje, Shpall, Elizabeth, Champlin, Richard, and Popat, Uday
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Ascites ,Hematopoietic Stem Cell Transplantation ,Hepatic Veno-Occlusive Disease ,Humans ,Incidence - Abstract
At our center, we observed a series of patients who developed transudative refractory ascites secondary to noncirrhotic, non-veno-occlusive disease (VOD)-related portal hypertension after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients were considered to have idiopathic portal hypertension-related refractory ascites (IRA) if they developed ascites secondary to intrahepatic portal hypertension (serum ascites albumin gradient ≥1.1 g/dL or hepatic venous pressure gradient [HVPG] >5 mm Hg), but did not meet the clinical criteria for classical VOD/sinusoidal obstructive syndrome (SOS) and did not have any alternate etiology of portal hypertension. From our institutional database, we identified 40 patients who developed IRA after allo-HSCT between 2004 and 2018. The patients median age at the time of allo-HSCT was 54 years (range, 21-73 years). The median time to development of IRA after allo-HSCT was 80 days (range, 16-576 days). The median number of paracentesis was 3 (range, 1-11), and 15 (38%) patients had an intraperitoneal catheter placed for continued drainage of the rapidly accumulating ascites. Portal pressures were measured in 19 patients; 6 (15%) had moderate portal hypertension (HVPG 6-9 mm Hg), and 13 (33%) had severe portal hypertension (HVPG ≥ 10 mm Hg). Liver biopsy was performed in 24 patients. None of the patients met the criteria for classical VOD/SOS (clinical/histological) or cirrhosis (histological). The cumulative incidence of nonrelapse mortality was 63%, and the median survival duration after the development of the IRA was 7 months (range, 0.8-125.6 months). IRA is a poorly understood and often fatal complication of allo-HSCT.
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- 2020
11. Outcome of Multiple Myeloma with Chromosome 1q Gain and 1p Deletion after Autologous Hematopoietic Stem Cell Transplantation: Propensity Score Matched Analysis.
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Varma, Ankur, Sui, Dawen, Milton, Denái, Tang, Guilin, Saini, Neeraj, Hasan, Omar, Mukherjee, Akash, Joseph, Jacinth, Bashir, Qaiser, Rondon, Gabriela, Srour, Samer, Popat, Uday, Hosing, Chitra, Nieto, Yago, Kebriaei, Partow, Alousi, Amin, Ahmed, Sairah, Mehta, Rohtesh, Khouri, Issa, Ahmed, Haris, Iyer, Swaminathan, Weber, Donna, Thomas, Sheeba, Manasanch, Elisabet, Lee, Hans, Patel, Krina, Ciurea, Stefan, Shpall, Elizabeth, Orlowski, Robert, Champlin, Richard, and Qazilbash, Muzaffar
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Autologous stem cell transplantation ,CDKN2C ,CKS1B ,Multiple myeloma ,Chromosomes ,Hematopoietic Stem Cell Transplantation ,Humans ,In Situ Hybridization ,Fluorescence ,Multiple Myeloma ,Propensity Score ,Retrospective Studies ,Transplantation ,Autologous ,Treatment Outcome - Abstract
The gain/amplification CKS1B gene at chromosome region 1q21 (1q+) is one of the most common genetic aberrations in multiple myeloma (MM). Amplification of CKS1B is frequently associated with the deletion of the CDKN2C gene at chromosome region 1p32 (1p-), which is also associated with inferior outcomes. In this retrospective study, we evaluated the outcomes of patients with 1q+ and/or 1p- after high-dose therapy and autologous hematopoietic cell transplantation (auto-HCT). From January 2006 to December 2015, 1491 newly diagnosed patients with MM underwent upfront high-dose therapy and auto-HCT at our institution. Of those, 899 had the fluorescent in situ hybridization (FISH) data available. FISH was performed at diagnosis and before the start of induction in 686 (76%) patients and after the initiation of induction therapy in 213 (24%) patients. We identified 100 patients with 1q+ and/or 1p- by FISH from the cohort of 899 patients. A control group (n = 287) with diploid cytogenetics and normal FISH panel was selected from the same cohort. From the above 2 cohorts, using a propensity score matched analysis, we identified matched controls for 85 of the 100 patients with 1q+/1p-. Patients were matched for age at auto-HCT, sex, International Staging System stage, induction regimen, creatinine level, disease status at auto-HCT, conditioning regimen, and maintenance therapy. Sixty-seven (79%), 4 (5%), and 14 (16%) patients had 1q+, 1p-, or both 1q+ and 1p-, respectively. There was no significant difference in induction therapy, preparative regimen, or maintenance therapy between the 1q+/1p- and the control group. The median follow-up time for all patients was 29.2 months (range, 0.29 to 84.96). The cumulative incidence of 100-day nonrelapse mortality was 1.2% and 0% for the 1q+/1p- and the control group, respectively. Forty-two patients (50%) in the 1q+/1p- group achieved complete response compared with 40 patients (47%) in the control group. The estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 41% and 79% for the 1q+/1p- group and 56% and 86% for the control group. Patients in the 1q+/1p- group were at significantly increased risk of progression or death compared to the control group (hazard ratio [HR], 2.21; confidence interval [CI], 1.18 to 4.16; P = .014). No significant association between OS in the 2 groups was observed. The outcome of the 1q+/1p- alone (with no additional high-risk cytogenetics) and the propensity score matched control groups was also compared. Median PFS for the 1q+/1p- alone subgroup was 26.6 months, compared with 38.8 months for the control group (HR, 1.9; CI, 0.9 to 4.08; P = .09). The median OS had not been reached for the 1q+/1p- alone subgroup and was 81.1 months for the control group (HR, 1.25; CI, 0.3 to 4.6; P= .73). 1q+/1p- abnormalities with amplification of CKS1B and deletion ofCDKN2Cgenes were associated with shorter PFS compared with a propensity score matched group of patients with diploid cytogenetics and normal a FISH panel. The outcomes of 1q+/1p- patients with MM have improved with the use of more effective induction, conditioning, and maintenance therapy compared with historical controls, but we still need more effective therapeutic approaches to fully overcome the negative impact of 1q+/1p-.
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- 2020
12. Myeloablative conditioning using timed-sequential busulfan plus fludarabine in older patients with acute myeloid leukemia: long-term results of a prospective phase II clinical trial
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Mehta, Rohtesh S, Bassett, Roland, Olson, Amanda, Chen, Julianne, Ahmed, Sairah, Alousi, Amin M, Anderlini, Paolo, Al-Atrash, Gheath, Bashir, Qaiser, Ciurea, Stefan O, Hosing, Chitra M, Im, Jin S, Kebriaei, Partow, Khouri, Issa, Marin, David, Molldrem, Jeffrey J, Nieto, Yago, Oran, Betul, Rezvani, Katayoun, Qazilbash, Muzaffar H, Srour, Samer A, Shpall, Elizabeth J, Andersson, Borje S, Champlin, Richard E, and Popat, Uday R
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Busulfan ,Combined Modality Therapy ,Female ,Follow-Up Studies ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Myeloablative Agonists ,Prognosis ,Prospective Studies ,Survival Rate ,Transplantation Conditioning ,Vidarabine ,Immunology - Published
- 2019
13. HLA Factors versus Non-HLA Factors for Haploidentical Donor Selection
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Mehta, Rohtesh S., Cao, Kai, Saliba, Rima M., Al-Atrash, Gheath, Alousi, Amin M., Lontos, Konstantinos, Marcoux, Curtis, Carmazzi, Yudith, Rondon, Gabriela, Bashir, Qaiser, Hosing, Chitra M., Kebriaei, Partow, Khouri, Issa, Marin, David, Nieto, Yago, Oran, Betul, Popat, Uday R., Qazilbash, Muzaffar H., Ramdial, Jeremy, Rezvani, Katayoun, Champlin, Richard E., and Shpall, Elizabeth J.
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- 2023
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14. Allogeneic Transplantation after Myeloablative Rituximab/BEAM ± Bortezomib for Patients with Relapsed/Refractory Lymphoid Malignancies: 5-Year Follow-Up Results
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Chamoun, Kamal, Milton, Denái R, Ledesma, Celina, Young, Ken H, Jabbour, Elias J, Alatrash, Gheath, Anderlini, Paolo, Bashir, Qaiser, Ciurea, Stefan O, Marin, David, Molldrem, Jeffrey J, Olson, Amanda L, Oran, Betul, Popat, Uday R, Rondon, Gabriela, Champlin, Richard E, Gulbis, Alison M, and Khouri, Issa F
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Rare Diseases ,Orphan Drug ,Prevention ,Hematology ,Lymphoma ,Cancer ,Transplantation ,Clinical Research ,6.2 Cellular and gene therapies ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adult ,Age Factors ,Aged ,Allografts ,Antineoplastic Combined Chemotherapy Protocols ,Bortezomib ,Carmustine ,Cytarabine ,Disease-Free Survival ,Female ,Hematologic Neoplasms ,Humans ,Lymphoma ,Large B-Cell ,Diffuse ,Male ,Melphalan ,Middle Aged ,Podophyllotoxin ,Rituximab ,Stem Cell Transplantation ,Survival Rate ,Myeloablative allogeneic transplantation ,R-BEAM ,Clinical Sciences ,Immunology ,Cardiovascular medicine and haematology - Abstract
Although bortezomib and rituximab have synergistic activity in patients with lymphoma and both can attenuate graft-versus-host disease (GVHD), the drugs have not been used together in patients undergoing allogeneic stem cell transplantation (alloSCT). In this phase I/II trial, we assessed the safety and activity of bortezomib added to the rituximab (R) plus BEAM (carmustine, etoposide, cytarabine, melphalan) regimen in patients with relapsed lymphoma undergoing alloSCT. Primary GVHD prophylaxis consisted of tacrolimus and methotrexate. Bortezomib (1 to 1.3 mg/m2 per dose) was administered i.v. on days -13, -6, -1, and +2. We performed inverse probability weighting analysis to compare GVHD and survival results with an historical control group that received R-BEAM without bortezomib. Thirty-nine patients were assessable for toxic effects and response. The median age was 54 years. The most common diagnosis was diffuse large B cell lymphoma (41%). Twenty-two patients (56%) and 17 patients (44%) received their transplants from matched related and matched unrelated donors, respectively. The maximum tolerated bortezomib dose was 1 mg/m2. The weighted cumulative incidences of grades II to IV and III or IV acute GVHD were 50% and 34%, respectively; these incidences and survival rates were not significantly different from those of the control group. Median survival was not reached in patients age ≤ 50 years and with a long follow-up time of 60.7 months. The R-BEAM regimen has a survival benefit in lymphoma patients age ≤ 50 years undergoing alloSCT. The addition of bortezomib has no impact on survival or incidence of GVHD.
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- 2019
15. Impact of Donor Type and Melphalan Dose on Allogeneic Transplantation Outcomes for Patients with Lymphoma
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Saini, Neeraj Y, Saliba, Rima M, Rondon, Gabriela, Maadani, Farzaneh, Popat, Uday, Hosing, Chitra M, Oran, Betul, Bashir, Qaiser, Olson, Amanda, Nieto, Yago, Alousi, Amin, Kebriaei, Partow, Srour, Samer, Mehta, Rohtesh, Anderlini, Paolo, Shpall, Elizabeth J, Qazilbash, Muzaffar H, Khouri, Issa F, Fayad, Luis, Lee, Hun, Fowler, Nathan, Parmar, Simrit, Westin, Jason, Hagemeister, Fredrick, Champlin, Richard E, and Ciurea, Stefan O
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Immunology ,Regenerative Medicine ,Transplantation ,Cancer ,Orphan Drug ,Hematology ,Rare Diseases ,Lymphoma ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Allografts ,Disease-Free Survival ,Female ,Graft vs Host Disease ,Humans ,Incidence ,Male ,Melphalan ,Middle Aged ,Retrospective Studies ,Stem Cell Transplantation ,Survival Rate ,Tissue Donors ,Vidarabine ,Allogeneic transplantation ,FM100 regimen ,Haploidentical transplantation ,Hodgkin lymphoma ,Melphalan conditioning ,Non-Hodgkin lymphoma ,Clinical Sciences ,Cardiovascular medicine and haematology - Abstract
We analyzed 186 patients with lymphoma who underwent allogeneic stem cell transplantation (ASCT) with fludarabine-melphalan (FM) conditioning and different types of donors (25 haploidentical [HD], 98 matched unrelated [MUD], and 63 matched related [MRD]) at our institution between September 2009 and January 2018. Patients received fludarabine 160 mg/m2 (40 mg/m2/day for 4 days) in combination with 1 dose of melphalan 140 mg/m2 (FM140) or 100 mg/m2 (FM100). Engraftment was similar among the 3 groups (92%, 89%, and 98%, respectively; P = .7). The 6-month cumulative incidence of grade III-IV acute graft-versus-host disease (GVHD) was 4% in the HD group, 14% in the MUD group, and 8% in the MRD group (P not significant), and the respective 3-year cumulative incidence of chronic GVHD was 5%, 16%, and 26% (P not significant). The respective 3-year nonrelapse mortality and relapse rates were 31%, 32%, and 10% (HD versus MUD, P = .9; HD versus MRD, P = .02) and 15%, 21%, and 39% (HD versus MUD, P = .4; HD versus MRD, P = .04). At 3 years, progression-free survival (PFS) was 59%, 44%, and 46% (P not significant); overall survival (OS) was 52%, 54%, and 67% (P not significant); and GVHD-free, relapse-free survival was 39%, 31%, and 24% (P not significant). No differences in the 3-year PFS (57% versus 43%; P = .3) and OS (64% versus 58%; P = .7) were seen between patients receiving FM100 and those receiving FM140. Our data demonstrate that in patients with lymphoma, ASCT with HD transplants have similar outcomes as ASCT with HLA-matched transplants, and the FM100 conditioning regimen appears to be at least as effective as the FM140 regimen.
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- 2019
16. Impact of a novel prognostic model, hematopoietic cell transplant-composite risk (HCT-CR), on allogeneic transplant outcomes in patients with acute myeloid leukemia and myelodysplastic syndrome
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Kongtim, Piyanuch, Parmar, Simrit, Milton, Denái R, Perez, Jorge Miguel Ramos, Rondon, Gabriela, Chen, Julianne, Chilkulwar, Abhishek R, Al-Atrash, Gheath, Alousi, Amin, Andersson, Borje S, Im, Jin S, Hosing, Chitra M, Bashir, Qaiser, Khouri, Issa, Kebriaei, Partow, Oran, Betul, Popat, Uday, Champlin, Richard, and Ciurea, Stefan O
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Pediatric ,Stem Cell Research - Nonembryonic - Human ,Transplantation ,Stem Cell Research ,Childhood Leukemia ,Clinical Research ,Rare Diseases ,Pediatric Cancer ,Hematology ,Pediatric Research Initiative ,Cancer ,Adolescent ,Adult ,Aged ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Myelodysplastic Syndromes ,Prognosis ,Survival Rate ,Transplantation Conditioning ,Transplantation ,Homologous ,Treatment Outcome ,Young Adult ,Clinical Sciences ,Oncology and Carcinogenesis ,Immunology ,Cardiovascular medicine and haematology ,Oncology and carcinogenesis - Abstract
Outcomes after allogeneic stem-cell transplantation (AHSCT) are influenced by both disease- and patient-related factors. Here, we developed a novel prognostic model, hematopoietic cell transplant-composite risk (HCT-CR), by combining the refined disease risk index (DRI-R) and hematopoietic stem-cell transplant comorbidity/age index (HCT-CI/Age) to predict post-transplant survival for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The analysis included 942 AML/MDS patients treated with AHSCT. Patients were stratified into 4 HCT-CR risk groups: Low-risk-patients with low/intermediate DRI-R and HCT-CI/Age ≤3 (N = 272); Intermediate-risk-patients with low/intermediate DRI-R and HCT-CI/Age >3 (N = 168); High-risk-patients with high/very high DRI-R and HCT-CI/Age ≤3 (N = 284); and Very high-risk-patients with high/very high DRI-R and HCT-CI/Age >3 (N = 184). Compared with the low-risk group, intermediate, high, and very high-risk groups had a significantly increased risk of death [adjusted HR of 1.37 (P
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- 2019
17. Pilot study using post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate GVHD prophylaxis for older patients receiving 10/10 HLA-matched unrelated donor hematopoietic stem cell transplantation.
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Shah, Mithun, Saliba, Rima, Rondon, Gabriela, Chen, Julianne, Soebbing, Doris, Rus, Ioana, Alousi, Amin, Oran, Betul, Kebriaei, Partow, Qazilbash, Muzaffar, Parmar, Simrit, Hosing, Chitra, Khouri, Issa, Popat, Uday, Champlin, Richard, and Ciurea, Stefan
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Cyclophosphamide ,Female ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Mycophenolic Acid ,Pilot Projects ,Prospective Studies ,Tacrolimus ,Transplantation Conditioning ,Unrelated Donors - Abstract
Allogeneic SCT for older patients remains challenging at least in part due to graft-versus-host disease (GVHD) and higher non-relapse mortality (NRM). We conducted a prospective pilot study primarily for older patients undergoing matched unrelated donor (MUD) SCT using a reduced-intensity (RIC) melphalan-based conditioning and post-transplant cyclophosphamide (PTCy)-based GVHD prophylaxis with tacrolimus and mycophenolate mofetil. Twenty-two patients (median age 64, IQR 58, 66) underwent RIC MUD SCT for high-risk hematological malignancies including AML/MDS (73%), CML/MPD (18%), and other (10%). Two (9%) patients had early death; the rest (100%) engrafted. After a median follow-up of 17 months, 11 patients were alive and disease-free with an estimated 2-year progression-free (PFS) and overall (OS) survival of 48%. The cumulative incidences of grades 2-4 and 3-4 acute GVHD (aGVHD) at day + 100 and 2-years were 32 and 4%, and 59 and 24%, respectively. No cases of chronic GVHD (cGVHD) were noted. However, late acute GVHD was observed in 6 (27%) patients. In conclusion, RIC MUD SCT with melphalan-based conditioning and PTCy-based GVHD-based prophylaxis for older patients appears effective in controlling relapse. While cGVHD was not seen and early aGVHD appears controllable, a significant proportion developed late aGVHD responsible for higher NRM seen in these patients.
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- 2019
18. Fludarabine with a higher versus lower dose of myeloablative timed-sequential busulfan in older patients and patients with comorbidities: an open-label, non-stratified, randomised phase 2 trial
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Popat, Uday R, Mehta, Rohtesh S, Bassett, Roland, Chen, Julianne, Valdez, Benigno C, Kawedia, Jitesh, Ahmed, Sairah, Alousi, Amin M, Anderlini, Paolo, Al-Atrash, Geath, Bashir, Qaiser, Ciurea, Stefan O, Hosing, Chitra M, Im, Jin S, Jones, Roy, Kebriaei, Partow, Khouri, Issa, Marin, David, Nieto, Yago, Olson, Amanda, Oran, Betul, Parmar, Simrit, Rezvani, Katayoun, Qazilbash, Muzaffar H, Shah, Nina, Srour, Samer A, Shpall, Elizabeth J, Champlin, Richard E, and Andersson, Borje S
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Transplantation ,Clinical Trials and Supportive Activities ,Cancer ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Busulfan ,Child ,Comorbidity ,Dose-Response Relationship ,Drug ,Drug Interactions ,Female ,Hematologic Neoplasms ,Humans ,Male ,Middle Aged ,Time Factors ,Treatment Outcome ,Vidarabine ,Young Adult ,Cardiorespiratory Medicine and Haematology ,Cardiovascular medicine and haematology - Abstract
BackgroundHaemopoietic stem-cell transplantation (HCT) conditioning regimens that can reduce risk of relapse without increasing non-relapse mortality are needed. We aimed to test the safety of timed-sequential delivery of low-dose versus high-dose myeloablative busulfan in older patients and patients with comorbidities.MethodsThis non-stratified, open-label, randomised phase 2 trial was done at The University of Texas MD Anderson Cancer Center (Houston, TX, USA). Patients with haematological cancers aged between 5 and 75 years were eligible to participate in the study. Patients who had HIV or uncontrollable infections were excluded. Eligible patients were randomly assigned (1:1 by a computer-generated programme in block sizes of four) to receive a total intravenous busulfan dose to achieve an area under the curve of 16 000 μmol/min (16K group) or 20 000 μmol/min (20K group) on the basis of pharmacokinetic analysis, plus intravenous fludarabine 40 mg/m2 for 4 days. The investigators and the research nurses were masked to the block size to conceal allocation. The primary outcome was day 100 non-relapse mortality. All analyses were by modified intention to treat, including only patients who received at least one dose of the study drug. No interim analyses were planned and accrual is complete. This study is registered with ClinicalTrials.gov, number NCT01572662.FindingsBetween April 18, 2012, and Dec 9, 2015, 98 patients were enrolled. 49 patients were randomly assigned to the 16K group and 49 to the 20K group, one of which was removed from the study before starting the intervention. Median age was 60 years (IQR 54-67). 50 (52%) patients had an HCT-specific comorbidity index score of 3 or more, and 41 (42%) had a high or very high Disease Risk Index score. Day 100 non-relapse mortality was 4% (95% CI 0-10) in the 16K group and 6% (0-13) in the 20K group (p=0·65). Infection was the most common grade 3-5 toxicity in both the 20K group (25 [52%] of 48 patients) and the 16K group (24 [49%] of 49 participants). Mucositis (nine [19%] of 48 patients vs three [6%] of 49 patients), idiopathic pneumonia syndrome (nine [19%] of 48 patients vs two [4%] of 49 patients), and culture-negative neutropenic fever (16 [33%] of 48 patients vs eight [16%] of 49 patients) were more common in the 20K group than in the 16K group.InterpretationMyeloablative doses of busulfan administered in a timed-sequential manner with fludarabine is associated with low non-relapse mortality in older patients and patients with comorbidities. Additional studies are required to show whether this approach can reduce the risk of relapse.FundingCancer Center Support Grant (US National Cancer Institute, National Institutes of Health).
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- 2018
19. Autologous stem cell transplantation for large B-cell lymphoma with secondary central nervous system involvement
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Akin, Serkan, Hosing, Chitra, Khouri, Issa, Ahmed, Sairah, Alousi, Amin, Fowler, Nathan, Joseph, Jacinth, Truxillo, Jonathan, Ramdial, Jeremy L., Maadani, Farzaneh, Rondon, Gabriela, Daher, May, Im, Jin S., Steiner, Raphael, Westin, Jason, Iyer, Swaminathan P., Dabaja, Bouthaina, Anderlini, Paolo, Popat, Uday R., Qazilbash, Muzaffar H., Flowers, Christopher R., Shpall, Elizabeth, Champlin, Richard E., Nieto, Yago, and Srour, Samer A.
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- 2022
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20. Allogeneic hematopoietic cell transplantation for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
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Bashir, Qaiser, Milton, Denái R., Popat, Uday R., Kebriaei, Partow, Hosing, Chitra, Khouri, Issa F., Rezvani, Katayoun, Nieto, Yago, Oran, Betul, Srour, Samer A., Saini, Neeraj Y., Olson, Amanda L., Ahmed, Sairah, Al-Atrash, Gheath, Rondon, Gabriela, Konopleva, Marina Y., Champlin, Richard E., Shpall, Elizabeth J., Qazilbash, Muzaffar H., and Pemmaraju, Naveen
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- 2022
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21. Blinatumomab maintenance after allogeneic hematopoietic cell transplantation for B-lineage acute lymphoblastic leukemia
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Gaballa, Mahmoud R., Banerjee, Pinaki, Milton, Denái R., Jiang, Xianli, Ganesh, Christina, Khazal, Sajad, Nandivada, Vandana, Islam, Sanjida, Kaplan, Mecit, Daher, May, Basar, Rafet, Alousi, Amin, Mehta, Rohtesh, Alatrash, Gheath, Khouri, Issa, Oran, Betul, Marin, David, Popat, Uday, Olson, Amanda, Tewari, Priti, Jain, Nitin, Jabbour, Elias, Ravandi, Farhad, Kantarjian, Hagop, Chen, Ken, Champlin, Richard, Shpall, Elizabeth, Rezvani, Katayoun, and Kebriaei, Partow
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- 2022
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22. Is a matched unrelated donor search needed for all allogeneic transplant candidates?
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Ciurea, Stefan O, Bittencourt, Maria Cecilia Borges, Milton, Denái R, Cao, Kai, Kongtim, Piyanuch, Rondon, Gabriela, Chen, Julianne, Konopleva, Marina, Perez, Jorge M Ramos, Shazly, Mohammed F El, Aljadayeh, Majdi, Alvarez, Michele, Im, Jin, Al-Atrash, Gheath, Mehta, Rohtesh, Popat, Uday, Bashir, Qaiser, Oran, Betul, Hosing, Chitra M, Khouri, Issa F, Kebriaei, Partow, and Champlin, Richard E
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Organ Transplantation ,Clinical Research ,Transplantation ,Adolescent ,Adult ,Aged ,Child ,Haplotypes ,Hematologic Neoplasms ,Hematopoietic Stem Cell Transplantation ,Histocompatibility Testing ,Humans ,Middle Aged ,Remission Induction ,Risk Factors ,Survival Analysis ,Transplantation ,Haploidentical ,Transplantation ,Homologous ,Unrelated Donors ,Young Adult ,Cardiovascular medicine and haematology - Abstract
Donor availability for allogeneic transplantation remains an important factor in determining outcomes of a successful transplant. We examined outcomes of 242 patients treated over 3 years who had a matched unrelated donor (MUD) search at our institution. One hundred sixty patients (66%) had a 10 of 10 MUD identified, and 85 (53%) proceeded to MUD transplantation. White patients and those with common haplotypes were more likely to have a MUD identified (odds ratio [OR], 7.4 [P < .0001]; OR, 41.6 [P < .0001]), and were more likely to proceed to transplantation with a MUD (OR, 11.2 [P < .0001]; OR, 85.1 [P = .002]). In addition, patients who were newly diagnosed/in remission at the time of MUD search had a higher probability of receiving a transplant (OR, 2.01 [P = .013]) and better progression-free survival (PFS; P < .0001). In multivariate analysis for patients who received a transplant, donor type did not influence PFS at 3 years, which was 40% for MUD and 57% for haploidentical transplants, respectively (hazard ratio, 1.2 [P = .50]). In conclusion, race, haplotype frequency, and disease status at the time of MUD search influence the probability of identifying a MUD and receiving a transplant. Patients with a low likelihood of receiving a MUD transplant may proceed to a haploidentical transplant as soon as indicated, as this approach does not appear to compromise transplant outcomes.
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- 2018
23. Haploidentical Transplantation for Older Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome
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Ciurea, Stefan O, Shah, Mithun V, Saliba, Rima M, Gaballa, Sameh, Kongtim, Piyanuch, Rondon, Gabriela, Chen, Julianne, Wallis, Whitney, Cao, Kai, Konopleva, Marina, Daver, Naval, Cortes, Jorge, Ravandi, Farhad, Alousi, Amin, Ahmed, Sairah, Popat, Uday, Parmar, Simrit, Bashir, Qaiser, Betul, Oran, Hosing, Chitra, Shpall, Elizabeth J, Rezvani, Katayoun, Khouri, Issa F, Kebriaei, Partow, and Champlin, Richard E
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Immunology ,Hematology ,Regenerative Medicine ,Transplantation ,Stem Cell Research ,Pediatric Cancer ,Stem Cell Research - Nonembryonic - Human ,Orphan Drug ,Pediatric ,Childhood Leukemia ,Clinical Research ,Stem Cell Research - Nonembryonic - Non-Human ,Cancer ,Rare Diseases ,Aging ,6.1 Pharmaceuticals ,Aetiology ,Evaluation of treatments and therapeutic interventions ,2.1 Biological and endogenous factors ,Adult ,Aged ,Cyclophosphamide ,Graft vs Host Disease ,Humans ,Leukemia ,Myeloid ,Acute ,Middle Aged ,Myelodysplastic Syndromes ,Risk Factors ,Transplantation Conditioning ,Transplantation ,Haploidentical ,Treatment Outcome ,Haploidentical stem cell transplant ,Post-transplant cyclophosphamide ,Elderly patients ,Acute myeloid leukemia ,Myelodysplastic syndrome ,Clinical Sciences ,Cardiovascular medicine and haematology - Abstract
Allogeneic stem cell transplantation with HLA-matched donors is increasingly used for older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It remains unclear if haploidentical stem cell transplantation (haploSCT) is a suitable option for older patients with this disease. We analyzed 43 patients with AML/MDS (median age, 61 years) who underwent a haploSCT at our institution. All patients received a fludarabine-melphalan-based reduced-intensity conditioning regimen and post-transplant cyclophosphamide-based graft-versus-host disease (GVHD) prophylaxis. Except for 1 patient who had early death, the remaining 42 patients (98%) engrafted donor cells. The cumulative incidences of grades II to IV and III to IV acute GVHD at 6 months were 35% and 5%, respectively, and chronic GVHD at 2 years was 9%. After a median follow-up of 19 months, 2-year overall survival, progression-free survival (PFS), and relapse incidence were 42%, 42%, and 24%, respectively. Best PFS (74% at 2 years) was seen in patients with intermediate-/good-risk cytogenetics, in first or second remission (hazard ratio, .4; P = .05), and with a younger donor (≤40 years; hazard ratio, .2; P = .01). In conclusion, these data suggest that haploidentical transplantation is safe and effective for older AML/MDS patients. Disease status, cytogenetics, and younger donor age are predictors for improved survival in older patients receiving a haploidentical transplant.
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- 2018
24. Updated Results of Rituximab Pre- and Post-BEAM with or without 90Yttrium Ibritumomab Tiuxetan during Autologous Transplant for Diffuse Large B-cell Lymphoma.
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Chahoud, Jad, Sui, Dawen, Erwin, William, Gulbis, Alison, Korbling, Martin, Zhang, Mingzhi, Ahmed, Sairah, Alatrash, Gheath, Anderlini, Paolo, Ciurea, Stefan, Oran, Betul, Fayad, Luis, Bassett, Roland, Jabbour, Elias, Medeiros, L, Macapinlac, Homer, Young, Ken, and Khouri, Issa
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Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Autografts ,Biomarkers ,Tumor ,Carmustine ,Cause of Death ,Clinical Trials ,Phase II as Topic ,Combined Modality Therapy ,Cytarabine ,Disease-Free Survival ,Etoposide ,Female ,Graft Survival ,Hematopoietic Stem Cell Transplantation ,Humans ,Kaplan-Meier Estimate ,Lymphoma ,Large B-Cell ,Diffuse ,Male ,Melphalan ,Middle Aged ,Prognosis ,Randomized Controlled Trials as Topic ,Retreatment ,Rituximab ,Treatment Outcome ,Young Adult ,Yttrium Radioisotopes - Abstract
Purpose: We evaluated the effect on long-term survival of adding rituximab (R) to BEAM (carmustine, etoposide, cytarabine, and melphalan) conditioning with or without yttrium-90 ibritumomab tiuxetan (90YIT) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) undergoing autologous stem cell transplant (ASCT).Experimental design: Patients were enrolled on three consecutive phase II clinical trials. Patients received two doses of rituximab (375 and 1,000 mg/m2) during mobilization of stem cells, followed by 1,000 mg/m2 on days +1 and +8 after ASCT with R-BEAM or 90YIT-R-BEAM (90YIT dose of 0.4 mCi/kg) conditioning.Results: One hundred thirteen patients were enrolled, with 73 receiving R-BEAM and 40 receiving 90YIT-R-BEAM. All patients had a prior exposure to rituximab. The median follow-up intervals for survivors were 11.8, 8.1, and 4.2 years in the three trials, respectively. The 5-year disease-free survival (DFS) rates were 62% for R-BEAM and 65% for 90YIT-R-BEAM (P = 0.82). The 5-year overall survival rates were 73% and 77%, respectively (P = 0.65). In patients with de novo DLBCL, survival outcomes of the germinal center/activated b-cell histologic subtypes were similar with 5-year OS rates (P = 0.52) and DFS rates (P = 0.64), irrespective of their time of relapse (1 year) after initial induction chemotherapy (P = 0.97).Conclusions: Administering ASCT with rituximab during stem cell collection and immediately after transplantation induces long-term disease remission and abolishes the negative prognostic impact of cell-of-origin in patients with relapsed DLBCL. The addition of 90YIT does not confer a further survival benefit. Clin Cancer Res; 24(10); 2304-11. ©2018 AACR.
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- 2018
25. Impact of Fluid Overload as New Toxicity Category on Hematopoietic Stem Cell Transplantation Outcomes.
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Rondón, Gabriela, Saliba, Rima, Chen, Julianne, Ledesma, Celina, Alousi, Amin, Oran, Betul, Hosing, Chitra, Kebriaei, Partow, Khouri, Issa, Shpall, Elizabeth, Popat, Uday, Champlin, Richard, and Ciurea, Stefan
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Allogeneic stem cell transplantation ,Fluid overload ,Fluid retention ,Fluid toxicity ,Haploidentical transplantation ,Nonrelapse mortality ,Weight gain ,Adolescent ,Adult ,Aged ,Body Fluids ,Edema ,Female ,Hematologic Neoplasms ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Myelodysplastic Syndromes ,Transplantation Conditioning ,Weight Gain ,Young Adult - Abstract
Fluid overload (FO) commonly occurs during hospitalization for allogeneic hematopoietic stem cell transplantation. We hypothesized that FO is associated with transplantation outcomes and evaluated this complication in 2 cohorts of patients. FO was graded based on post-transplantation weight gain, symptoms, and need for treatment, scored in real time by an independent team. The first cohort (study cohort; n = 145) underwent haploidentical transplantation for hematologic malignancies following a melphalan-based conditioning regimen. In univariate analysis, factors associated with day +100 nonrelapse mortality (NRM) were FO grade ≥2 (hazard ratio [HR], 15; 95% confidence interval [CI], 4.2 to 55; P 1 mg/dL (HR, 4.7; 95% CI, 1.6 to 14; P = .005), and age >55 years (HR, 4.5; 95% CI, 1.5 to 13; P = .008). In multivariate analysis, factors associated with day +100 NRM were FO grade ≥2 (HR, 13.1; 95% CI, 3.4 to 50; P 1 mg/dL at transplantation admission (HR, 3.5; 95% CI, 1.1 to 11; P = .03). These findings were verified in a separate cohort (validation cohort) of patients with acute myelogenous leukemia/myelodysplastic syndrome who underwent HLA-matched transplantation with busulfan-based conditioning (n = 449). In multivariate analysis, factors associated with day +100 NRM were FO grade ≥2 (HR, 34; 95% CI, 7.2 to 158; P
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- 2017
26. Eltrombopag improves platelet engraftment after haploidentical bone marrow transplantation: Results of a Phase II study
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Ahmed, Sairah, primary, Bashir, Qaiser, additional, Bassett, Roland L., additional, Ullah, Fauzia, additional, Aung, Fleur, additional, Valdez, Benigno C., additional, Alousi, Amin M., additional, Hosing, Chitra, additional, Kebriaei, Partow, additional, Khouri, Issa, additional, Marin, David, additional, Nieto, Yago, additional, Olson, Amanda, additional, Oran, Betul, additional, Qazilbash, Muzaffar H., additional, Rezvani, Katayoun, additional, Mehta, Rohtesh, additional, Shpall, Elizabeth J., additional, Ciurea, Stefan, additional, Andersson, Borje S., additional, Champlin, Richard E., additional, and Popat, Uday R., additional
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- 2024
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27. Outcomes in patients with CRLF2 overexpressed acute lymphoblastic leukemia after allogeneic hematopoietic cell transplantation
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Koller, Paul, Saliba, Rima M., Ledesma, Celina, Rondon, Gabriela, Popat, Uday, Alousi, Amin, Mehta, Rohtesh, Oran, Betul, Olson, Amanda, Hosing, Chitra, Qazilbash, Muzaffar, Khouri, Issa, Ciurea, Stefan, Shpall, Elizabeth, Jorgensen, Jeffrey, Wang, Sa, Jain, Nitin, Jabbour, Elias, Kantarjian, Hagop, Champlin, Richard, Konopleva, Marina, and Kebriaei, Partow
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- 2021
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28. Feasibility of Lenalidomide Therapy for Persistent Chronic Lymphocytic Leukemia after Allogeneic Transplantation.
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Khouri, Maria, Jabbour, Elias, Gulbis, Alison, Turturro, Francesco, Ledesma, Celina, Korbling, Martin, Samuels, Barry, Ahmed, Sairah, Alousi, Amin, Ciurea, Stefan, Marin, David, Patel, Krina, Popat, Uday, Bueso-Ramos, Carlos, Bassett, Roland, and Khouri, Issa
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Allogeneic ,Chronic lymphocytic leukemia ,Lenalidomide ,Nonmyeloablative ,Transplantation ,Acute Disease ,Aged ,Allografts ,Disease-Free Survival ,Female ,Follow-Up Studies ,Graft vs Host Disease ,Humans ,Lenalidomide ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Lymphocyte Transfusion ,Male ,Middle Aged ,Stem Cell Transplantation ,Survival Rate ,Thalidomide - Abstract
In patients with chronic lymphocytic leukemia (CLL), persistence of disease after allogeneic stem cell transplantation (alloSCT) can result in poor outcomes. In an effort to improve these outcomes, patients with persistent CLL who were 90 to 100 days beyond alloSCT with no evidence of graft-versus-host-disease (GVHD) were randomized to receive lenalidomide or standard care (withdrawal of immunosuppression followed by donor lymphocyte infusion). Lenalidomide was initiated at 5 mg every other day and increased to 10 mg daily, if tolerated, in each patient. Of 38 patients enrolled, 17 (45%) met the eligibility criteria for randomization. Of these 17 patients, 8 were randomized to undergo lenalidomide therapy. Five (62%) patients had to stop taking the drug because of toxicity. The main reason for drug discontinuation was acute GVHD in 43% of patients. This incidence was 11% in the patients who were randomized to not receive lenalidomide. With a median follow-up of 2.6 years, the median survival was 3.4 years for those receiving lenalidomide. This was not reached in patients randomized to not receive lenalidomide and in patients in complete remission who were not randomized. These results suggested that treatments other than lenalidomide are needed for persistent CLL after alloSCT.
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- 2017
29. Clofarabine Plus Busulfan is an Effective Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute Lymphoblastic Leukemia: Long-Term Study Results.
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Kebriaei, Partow, Bassett, Roland, Lyons, Genevieve, Valdez, Ben, Ledesma, Celina, Rondon, Gabriela, Oran, Betul, Ciurea, Stefan, Alousi, Amin, Popat, Uday, Patel, Krina, Ahmed, Sairah, Olson, Amanda, Bashir, Qaiser, Shah, Nina, Jones, Roy, Marin, David, Rezvani, Katayoun, Nieto, Yago, Khouri, Issa, Qazilbash, Muzaffar, Hosing, Chitra, Shpall, Elizabeth, Champlin, Richard, and Andersson, Borje
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Acute lymphoblastic leukemia ,Allogeneic hematopoietic stem cell transplantation ,Transplant conditioning regimens ,Adenine Nucleotides ,Adolescent ,Adult ,Allografts ,Arabinonucleosides ,Busulfan ,Clofarabine ,Disease-Free Survival ,Dose-Response Relationship ,Drug ,Female ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Male ,Middle Aged ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Transplantation Conditioning ,Whole-Body Irradiation ,Young Adult - Abstract
We investigated the long-term safety and disease control data obtained with i.v. busulfan (Bu) combined with clofarabine (Clo) in patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). A total of 107 patients, median age 38 years (range, 19 to 64 years) received a matched sibling donor (n = 52) or matched unrelated donor (n = 55) transplant for ALL in first complete remission (n = 62), second complete remission (n = 28), or more advanced disease (n = 17). Nearly one-half of the patients had a high-risk cytogenetic profile as defined by the presence of t(9;22) (n = 34), t(4;11) (n = 4), or complex cytogenetics (n = 7). Clo 40 mg/m2 was given once daily, with each dose followed by pharmacokinetically dosed Bu infused over 3 hours daily for 4 days, followed by hematopoietic cell infusion after 2 days of rest. The Bu dose was based on the drug clearance as determined by a test Bu dose of 32 mg/m2. The target daily area under the curve was 5500 µmol/min for patients aged 59 years. With a median follow-up of 3.3 years among surviving patients (range, 1 to 5.8 years), the 2-year progression-free survival (PFS) for patients undergoing HSCT in first complete remission (CR1), second complete remission (CR2), or more advanced disease was 62%, 34%, and 35%, respectively. The regimen was well tolerated, with nonrelapse mortality (NRM) of 10% at 100 days and 31% at 2 years post-HSCT. The incidence of grade II-IV and III-IV acute graft-versus-host disease (GVHD) was 35% and 10%, respectively; 18% patients developed extensive chronic GVHD. The 2-year overall survival (OS) for patients undergoing HSCT in CR1, CR2, or more advanced disease was 70%, 57%, and 35%, respectively. Among 11 patients aged >59 years treated with reduced-dose Bu in CR1 (n = 7) or CR2 (n = 4), 4 remain alive and disease-free, with a median follow-up of 2.6 years (range, 2 to 4.7 years). Only the presence of minimal residual disease at the time of transplantation was associated with significantly worse PFS and OS in multivariate analysis. Our data indicate that the Clo-Bu combination provides effective disease control while maintaining a favorable safety profile. OS and NRM rates compare favorably with those for traditional myeloablative total body irradiation-based conditioning regimens.
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- 2017
30. Prognostic impact of pretreatment cytogenetics in adult Philadelphia chromosome–negative acute lymphoblastic leukemia in the era of minimal residual disease
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Issa, Ghayas C, Kantarjian, Hagop M, Yin, C Cameron, Qiao, Wei, Ravandi, Farhad, Thomas, Deborah, Short, Nicholas J, Sasaki, Koji, Garcia‐Manero, Guillermo, Kadia, Tapan M, Cortes, Jorge E, Daver, Naval, Borthakur, Gautam, Jain, Nitin, Konopleva, Marina, Khouri, Issa, Kebriaei, Partow, Champlin, Richard E, Pierce, Sherry, O’Brien, Susan M, and Jabbour, Elias
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Hematology ,Childhood Leukemia ,Cancer ,Pediatric ,Rare Diseases ,Pediatric Cancer ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Cytarabine ,Cytodiagnosis ,Disease-Free Survival ,Doxorubicin ,Female ,Humans ,Leukemia ,Myeloid ,Chronic ,Atypical ,BCR-ABL Negative ,Male ,Middle Aged ,Neoplasm ,Residual ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Prognosis ,Remission Induction ,Treatment Outcome ,Vincristine ,acute lymphoblastic leukemia ,complex ,cytogenetics ,hypodiploidy ,minimal residual disease ,prognosis ,Public Health and Health Services ,Oncology & Carcinogenesis ,Oncology and carcinogenesis ,Public health - Abstract
BackgroundThe introduction of novel prognostic factors such as minimal residual disease (MRD) and genomic profiling has led to the reevaluation of the role of cytogenetics and other conventional factors in risk stratification for acute lymphoblastic leukemia (ALL).MethodsThis study assessed the impact of baseline cytogenetics on the outcomes of 428 adult patients with Philadelphia chromosome-negative ALL who were receiving frontline chemotherapy. Three hundred thirty patients (77%) were treated with hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone-based regimens, and 98 (23%) were treated with the augmented Berlin-Frankfurt-Munster regimen.ResultsThe median age was 40 years (range, 13-86 years). One hundred eighty-six patients (43%) had diploid cytogenetics, 32 (7%) had complex cytogenetics (defined as ≥ 5 chromosomal abnormalities), 27 (6%) had low hypodiploidy/near-triploidy (Ho-Tr), 24 (6%) had high hyperdiploidy, and 24 (6%) had a mixed-lineage leukemia (MLL) rearrangement. Patients with an MLL rearrangement, Ho-Tr, or a complex karyotype had significantly worse relapse-free survival (RFS) and overall survival (OS) than the diploid group. According to a multivariate analysis including all the baseline characteristics and MRD status, Ho-Tr and a complex karyotype were independent predictive factors for worse RFS and OS. Furthermore, survival among all cytogenetic groups was similar, regardless of the treatment received.ConclusionsA complex karyotype and Ho-Tr are adverse prognostic factors for adults with ALL independently of the MRD status. These findings suggest that pretreatment cytogenetics remain a valuable prognostic tool in this population. Cancer 2017;123:459-467. © 2016 American Cancer Society.
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- 2017
31. Differential impact of minimal residual disease negativity according to the salvage status in patients with relapsed/refractory B‐cell acute lymphoblastic leukemia
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Jabbour, Elias, Short, Nicholas J, Jorgensen, Jeffrey L, Yilmaz, Musa, Ravandi, Farhad, Wang, Sa A, Thomas, Deborah A, Khoury, Joseph, Champlin, Richard E, Khouri, Issa, Kebriaei, Partow, O'Brien, Susan M, Garcia-Manero, Guillermo, Cortes, Jorge E, Sasaki, Koji, Dinardo, Courtney D, Kadia, Tapan M, Jain, Nitin, Konopleva, Marina, Garris, Rebecca, and Kantarjian, Hagop M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Childhood Leukemia ,Cancer ,Rare Diseases ,Pediatric Research Initiative ,Pediatric ,Hematology ,Pediatric Cancer ,Clinical Research ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Antineoplastic Agents ,B-Lymphocytes ,Disease-Free Survival ,Hematopoietic Stem Cell Transplantation ,Humans ,Middle Aged ,Neoplasm Recurrence ,Local ,Neoplasm ,Residual ,Precursor B-Cell Lymphoblastic Leukemia-Lymphoma ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Salvage Therapy ,Stem Cell Transplantation ,Young Adult ,acute lymphoblastic leukemia ,blinatumomab ,inotuzumab ,minimal residual disease ,refractory ,relapsed ,Public Health and Health Services ,Oncology & Carcinogenesis ,Oncology and carcinogenesis ,Public health - Abstract
BackgroundMinimal residual disease (MRD) assessment predicts survival for patients with newly diagnosed acute lymphoblastic leukemia (ALL). Its significance in relapsed/refractory ALL is less clear.MethodsThis study identified 78 patients with relapsed/refractory B-cell ALL who achieved a morphologic response with inotuzumab ozogamicin (n = 41), blinatumomab (n = 11), or mini-hyperfractionated cyclophosphamide, vincristine, and doxorubicin plus inotuzumab (n = 26) during either salvage 1 (S1; n = 46) or salvage 2 (S2; n = 32) and had undergone an MRD assessment by multiparameter flow cytometry at the time of remission.ResultsMRD negativity was achieved in 41 patients overall (53%). The MRD negativity rate was 57% in S1 and 47% in S2. Among patients in S1, achieving MRD negativity was associated with longer event-free survival (EFS; median, 18 vs 7 months; 2-year EFS rate, 46% vs 17%; P = .06) and overall survival (OS; median, 27 vs 9 months; 2-year OS, 52% vs 36%; P = .15). EFS and OS were similar in S2, regardless of the MRD response. Among MRD-negative patients who underwent allogeneic stem cell transplantation (SCT), EFS and OS were superior for those who underwent SCT in S1 rather than S2 (P = .003 and P = .04, respectively). Patients in S1 who achieved MRD negativity and subsequently underwent SCT had the best outcomes with a 2-year OS rate of 65%.ConclusionsPatients with relapsed/refractory ALL who achieve MRD negativity in S1 can have long-term survival. Patients in S2 generally have poor outcomes, regardless of their MRD status. Cancer 2017;123:294-302. © 2016 American Cancer Society.
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- 2017
32. Randomized phase II trial of extracorporeal phototherapy and steroids vs. steroids alone for newly diagnosed acute GVHD
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Mehta, Rohtesh S., Bassett, Roland, Rondon, Gabriela, Overman, Bethany J., Popat, Uday R., Hosing, Chitra M., Rezvani, Katy, Qazilbash, Muzaffar H., Anderlini, Paolo, Jones, Roy B., Kebriaei, Partow, Marin, David, Khouri, Issa F., Oran, Betul, Ciurea, Stefan O., Kondo, Kayo, Couriel, Daniel R., Shpall, Elizabeth J., Champlin, Richard E., and Alousi, Amin M.
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- 2021
- Full Text
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33. Prognostic significance of day 14 bone marrow evaluation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia.
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Short, Nicholas, Kantarjian, Hagop, Sasaki, Koji, Cortes, Jorge, Ravandi, Farhad, Thomas, Deborah, Garcia-Manero, Guillermo, Khouri, Issa, Kebriaei, Partow, Champlin, Richard, Pierce, Sherry, Issa, Ghayas, Konopleva, Marina, Kadia, Tapan, Bueso-Ramos, Carlos, Khoury, Joseph, Jain, Nitin, Jabbour, Elias, and OBrien, Susan
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acute lymphoblastic leukemia ,blasts ,day 14 ,minimal residual disease ,prognosis ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Bone Marrow ,Bone Marrow Examination ,Disease-Free Survival ,Female ,Humans ,Induction Chemotherapy ,Male ,Middle Aged ,Multivariate Analysis ,Neoplasm ,Residual ,Philadelphia Chromosome ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Prognosis ,Proportional Hazards Models ,Remission Induction ,Young Adult - Abstract
BACKGROUND: The role of day 14 (D14) bone marrow (BM) assessment in detecting increased blasts in patients undergoing induction for acute lymphoblastic leukemia (ALL) is not well defined. METHODS: This study evaluated 389 adolescent and adult patients with previously untreated Philadelphia chromosome-negative ALL who received frontline induction chemotherapy and for whom a D14 BM assessment was performed. RESULTS: A D14 BM blast proportion
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- 2016
34. Results of a 2‐arm, phase 2 clinical trial using post‐transplantation cyclophosphamide for the prevention of graft‐versus‐host disease in haploidentical donor and mismatched unrelated donor hematopoietic stem cell transplantation
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Gaballa, Sameh, Ge, Isabell, El Fakih, Riad, Brammer, Jonathan E, Kongtim, Piyanuch, Tomuleasa, Ciprian, Wang, Sa A, Lee, Dean, Petropoulos, Demetrios, Cao, Kai, Rondon, Gabriela, Chen, Julianne, Hammerstrom, Aimee, Lombardi, Lindsey, Alatrash, Gheath, Korbling, Martin, Oran, Betul, Kebriaei, Partow, Ahmed, Sairah, Shah, Nina, Rezvani, Katayoun, Marin, David, Bashir, Qaiser, Alousi, Amin, Nieto, Yago, Qazilbash, Muzaffar, Hosing, Chitra, Popat, Uday, Shpall, Elizabeth J, Khouri, Issa, Champlin, Richard E, and Ciurea, Stefan O
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Regenerative Medicine ,Prevention ,Orphan Drug ,Stem Cell Research - Nonembryonic - Human ,Clinical Trials and Supportive Activities ,Hematology ,Clinical Research ,Rare Diseases ,Cancer ,Stem Cell Research ,Transplantation ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Cyclophosphamide ,Drug Therapy ,Combination ,Feasibility Studies ,Female ,Follow-Up Studies ,Graft vs Host Disease ,Hematologic Neoplasms ,Hematopoietic Stem Cell Transplantation ,Histocompatibility Testing ,Humans ,Immunosuppressive Agents ,Male ,Middle Aged ,Mycophenolic Acid ,Prognosis ,Prospective Studies ,Tacrolimus ,Transplantation Conditioning ,Transplantation ,Homologous ,Unrelated Donors ,Young Adult ,9/10 matched unrelated donors ,graft-versus-host disease ,haploidentical transplantation ,hematologic malignancies ,post-transplantation cyclophosphamide ,Oncology and Carcinogenesis ,Public Health and Health Services ,Oncology & Carcinogenesis - Abstract
BackgroundHigh-dose, post-transplantation cyclophosphamide (PTCy) to prevent graft-versus-host disease (GVHD) has improved outcomes in haploidentical (HAPLO) stem cell transplantation (SCT). However, it remains unclear whether this strategy is effective in SCT from 1-antigen human leukocyte antigen (HLA)-mismatched unrelated donors (9/10 MUD) and how the outcomes of these patients compare with those of haploidentical transplantation recipients.MethodsA parallel, 2-arm, nonrandomized phase 2 clinical trial was conducted of melphalan-based reduced-intensity conditioning with PTCy, tacrolimus, and mycophenolate mofetil to prevent GVHD in patients with high-risk hematologic malignancies who underwent HAPLO (n = 60) or 9/10 MUD (n = 46) SCT.ResultsThe 1-year overall and progression-free survival rates were 70% and 60%, respectively, in the HAPLO arm and 60% and 47%, respectively, in the 9/10 MUD arm. The day +100 cumulative incidence of grade II to IV acute GVHD and grade III to IV acute GVHD was 28% and 3%, respectively, in the HAPLO arm and 33% and 13%, respectively, in the 9/10 MUD arm. The 2-year cumulative incidence of chronic GVHD was 24% in the HAPLO arm and 19% in the 9/10 MUD arm. The 1-year cumulative incidence of nonrelapse mortality was 21% in the HAPLO arm and 31% in the 9/10 MUD arm, and the 1-year relapse rate was 19% in the HAPLO arm and 25% in the 9/10 MUD arm.ConclusionsAlthough this was a nonrandomized study and could not serve as a direct comparison between the 2 groups, the authors conclude that PTCy-based GVHD prophylaxis is effective for both HAPLO and 9/10 MUD SCTs. Prospective randomized trials will be required to compare the efficacies of alternative donor options for patients lacking HLA-matched donors. Cancer 2016;122:3316-3326. © 2016 American Cancer Society.
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- 2016
35. Can we cure refractory Hodgkin’s lymphoma with transplantation?
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Ciurea, Stefan O., Kongtim, Piyanuch, Srour, Samer, Saini, Neeraj, Im, Jin, Ramdial, Jeremy, Khouri, Issa, Anderlini, Paolo, Popat, Uday, Hosing, Chitra, Champlin, Richard E., Lee, Hun J., Fayad, Luis E., Hagemeister, Fredrick B., Bica, Ana M., Lipan, Lavinia, Craciun, Oana, Jercan, Cristina G., Tanase, Alina, and Colita, Anca
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- 2021
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36. Safety and long‐term survival results of the addition of inotuzumab ozogamicin to the conditioning regimen of allogeneic stem cell transplantation: A single‐center phase 1,2 trial.
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Khouri, Issa F., Alzahrani, Kamal, Kantarjian, Hagop, Milton, Denái R., Gulbis, Alison M., Sasaki, Koji, Jain, Nitin, Short, Nicholas J., Kadia, Tapan, Daher, May, Rafei, Hind, Im, Jin S., Marin, David, Olson, Amanda L., Popat, Uday, Qazilbash, Muzaffar, Ramdial, Jeremy, Rondon, Gabriela, Srour, Samer, and Kebriaei, Partow
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- 2024
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37. Hyper-CVAD regimen in combination with ofatumumab as frontline therapy for adults with Philadelphia chromosome-negative B-cell acute lymphoblastic leukaemia: a single-arm, phase 2 trial
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Jabbour, Elias, Richard-Carpentier, Guillaume, Sasaki, Yuya, Konopleva, Marina, Patel, Keyur, Roberts, Kathryn, Gu, Zhaohui, Wang, Feng, Huang, Xuelin, Sasaki, Koji, Short, Nicholas J, Jain, Nitin, Ravandi, Farhad, Daver, Naval G, Kadia, Tapan M, Alvarado, Yesid, DiNardo, Courtney D, Issa, Ghayas C, Pemmaraju, Naveen, Garcia-Manero, Guillermo, Verstovsek, Srdan, Wang, Sa, Khoury, Joseph D, Jorgensen, Jeffrey, Champlin, Richard, Khouri, Issa, Kebriaei, Partow, Schroeder, Heather, Khouri, Maria, Mullighan, Charles G, Takahashi, Koichi, O'Brien, Susan M, and Kantarjian, Hagop
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- 2020
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38. Age Is a Prognostic Factor for the Overall Survival of Patients with Multiple Myeloma Undergoing Upfront Autologous Hematopoietic Stem Cell Transplantation
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Cordas dos Santos, David M., Saliba, Rima M., Patel, Romil, Bashir, Qaiser, Saini, Neeraj, Hosing, Chitra, Kebriaei, Partow, Khouri, Issa F., Nieto, Yago, Popat, Uday, Ahmed, Haris, Lee, Hans C., Manasanch, Elisabet E., Patel, Krina K., Thomas, Sheeba K., Weber, Donna M., Orlowski, Robert Z., Champlin, Richard E., and Qazilbash, Muzaffar H.
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- 2020
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39. Novel Disease Risk Model for Patients with Acute Myeloid Leukemia Receiving Allogeneic Hematopoietic Cell Transplantation
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Kongtim, Piyanuch, Hasan, Omar, Perez, Jorge Miguel Ramos, Varma, Ankur, Wang, Sa A., Patel, Keyur P., Chen, Julianne, Rondon, Gabriela, Srour, Samer, Bashir, Qaiser, Qazilbash, Muzaffar, Mehta, Rohtesh, Shpall, Elizabeth J., Alousi, Amin, Khouri, Issa, Kebriaei, Partow, Popat, Uday, Champlin, Richard R., and Ciurea, Stefan O.
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- 2020
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40. Pure Red Cell Aplasia in Major ABO-Mismatched Allogeneic Hematopoietic Stem Cell Transplantation Is Associated with Severe Pancytopenia.
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Aung, Fleur, Lichtiger, Benjamin, Rondon, Gabriela, Yin, C, Alousi, Amin, Ahmed, Sairah, Andersson, Borje, Bashir, Qaiser, Ciurea, Stefan, Hosing, Chitra, Jones, Roy, Kebriaei, Partow, Khouri, Issa, Nieto, Yago, Oran, Betul, Parmar, Simrit, Qazilbash, Muzaffar, Shah, Nina, Shpall, Elizabeth, Champlin, Richard, and Popat, Uday
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Hematopoietic stem cell transplant ,Pancytopenia ,Pure red cell aplasia ,ABO Blood-Group System ,Adult ,Aged ,Allografts ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Male ,Middle Aged ,Pancytopenia ,Red-Cell Aplasia ,Pure ,Retrospective Studies ,Severity of Illness Index ,Time Factors - Abstract
In major ABO-mismatched allogeneic hematopoietic stem cell transplantation (HSCT) persistence of antidonor isohemagglutinins leads to pure red cell aplasia (PRCA). To investigate severe pancytopenia noted in a previous study of PRCA, we analyzed all major ABO-mismatched HSCT between January 2003 and December 2012. Of 83 PRCA patients, 13 (16%) had severe pancytopenia. Severe pancytopenia was defined as an absolute neutrophil count (ANC)
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- 2016
41. Post-transplantation cyclophosphamide versus conventional graft-versus-host disease prophylaxis in mismatched unrelated donor haematopoietic cell transplantation.
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Mehta, Rohtesh, Saliba, Rima, Chen, Julianne, Rondon, Gabriela, Hammerstrom, Aimee, Alousi, Amin, Qazilbash, Muzaffar, Bashir, Qaiser, Ahmed, Sairah, Popat, Uday, Hosing, Chitra, Khouri, Issa, Shpall, Elizabeth, Champlin, Richard, and Ciurea, Stefan
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GVHD ,HLA-mismatched transplantation ,MMUD ,post transplantation cyclophosphamide ,unrelated donor ,Adult ,Aged ,Cyclophosphamide ,Female ,Graft Survival ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Histocompatibility ,Humans ,Male ,Middle Aged ,Mycophenolic Acid ,Premedication ,Retrospective Studies ,Tacrolimus ,Unrelated Donors ,Young Adult - Abstract
Post-transplantation cyclophosphamide (PTCy) is an effective strategy to prevent graft-versus-host disease (GVHD) after haploidentical haematopoietic cell transplantation (HCT). We determined the efficacy of PTCy-based GVHD prophylaxis in human leucocyte antigen (HLA)-mismatched unrelated donor (MMUD) HCT. We analysed 113 adult patients with high-risk haematological malignancies who underwent one-antigen MMUD transplantation between 2009 and 2013. Of these, 41 patients received PTCy, tacrolimus and mycophenolate mofetil (MMF) for GVHD prophylaxis; 72 patients received conventional prophylaxis with anti-thymocyte globulin, tacrolimus and methotrexate. Graft source was primarily bone marrow (83% PTCy vs. 63% conventional group). Incidence of grade II-IV (37% vs. 36%, P = 0·8) and grade III-IV (17% vs. 12%, P = 0·5) acute GVHD was similar at day 100. However, the incidence of grade II-IV acute GVHD by day 30 was significantly lower in the PTCy group (0% vs. 15%, P = 0·01). Median time to neutrophil (18 days vs. 12 days, P
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- 2016
42. Treatment with Hypomethylating Agents before Allogeneic Stem Cell Transplant Improves Progression-Free Survival for Patients with Chronic Myelomonocytic Leukemia.
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Popat, Uday, Jimenez, Antonio, Gaballa, Sameh, El Fakih, Riad, Rondon, Gabriela, Chen, Julianne, Bueso-Ramos, Carlos, Borthakur, Gautam, Pemmaraju, Naveen, Garcia-Manero, Guillermo, Kantarjian, Hagop, Alousi, Amin, Hosing, Chitra, Anderlini, Paolo, Khouri, Issa, Kebriaei, Partow, Andersson, Borje, Oran, Betul, Rezvani, Katayoun, Marin, David, Shpall, Elizabeth, Champlin, Richard, Ciurea, Stefan, and Kongtim, Piyanuch
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Allogeneic stem cell transplantation ,Chronic myelomonocytic leukemia ,Hypomethylating agents ,Myeloproliferative neoplasms ,Secondary acute myeloid leukemia ,Adenine Nucleotides ,Adolescent ,Adult ,Aged ,Allografts ,Antineoplastic Combined Chemotherapy Protocols ,Arabinonucleosides ,Clofarabine ,Cytarabine ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Leukemia ,Myelogenous ,Chronic ,BCR-ABL Positive ,Male ,Middle Aged ,Retrospective Studies ,Stem Cell Transplantation ,Survival Rate - Abstract
The treatment of patients with chronic myelomonocytic leukemia (CMML) with transplant has not been optimized. We retrospectively reviewed the data for 83 consecutive patients with CMML (47 with CMML-1/2 and 36 with CMML progressed to acute myeloid leukemia) who received an allogeneic stem cell transplant (allo-SCT) at our institution between April 1991 and December 2013 to identify factors associated with improved survival and determine whether treatment with hypomethylating agents before transplant improves progression-free survival (PFS). The median age of the cohort was 57 years. Seventy-eight patients received induction treatment before transplant, with 37 receiving hypomethylating agents and 41 receiving cytotoxic chemotherapy. Patients treated with a hypomethylating agent had a significantly lower cumulative incidence of relapse at 3 years post-transplant (22%) than those treated with other agents (35%; P = .03), whereas treatment-related mortality at 1 year post-transplant did not significantly differ between the groups (27% and 30%, respectively; P = .84). The lower relapse rate resulted in a significantly higher 3-year PFS rate in patients treated with a hypomethylating agent (43%) than in those treated with other agents (27%; P = .04). Our data support the use of hypomethylating agents before allo-SCT for patients with CMML to achieve morphologic remission and improve PFS of these patients. Future studies are needed to confirm these findings.
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- 2016
43. Age and Modified European LeukemiaNet Classification to Predict Transplant Outcomes: An Integrated Approach for Acute Myelogenous Leukemia Patients Undergoing Allogeneic Stem Cell Transplantation.
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Oran, Betül, Jimenez, Antonio, De Lima, Marcos, Popat, Uday, Bassett, Roland, Andersson, Borje, Borthakur, Gautam, Bashir, Qaiser, Chen, Julianne, Ciurea, Stefan, Jabbour, Elias, Cortes, Jorge, Kebriaei, Partow, Khouri, Issa, Qazilbash, Muzaffar, Ravandi, Farhad, Rondon, Gabriela, Lu, Xinyan, Shpall, Elizabeth, and Champlin, Richard
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AML ,Allogeneic stem cell transplantation ,European LeukemiaNet ,Prognosis ,Adult ,Age Factors ,Europe ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Retrospective Studies ,Risk Factors ,Survival Rate ,Transplantation Conditioning ,Transplantation ,Homologous ,Treatment Outcome - Abstract
We evaluated the prognostic significance of a modified European LeukemiaNet (ELN) classification for patients with acute myelogenous leukemia (AML) undergoing hematopoietic stem cell transplantation (HSCT) while in first complete remission (CR1). We analyzed 464 AML patients with matched related (n = 211, 45.5%), matched unrelated (n = 176, 37.9%), and mismatched donors (n = 77, 16.6%). Patients were classified into 4 modified ELN risk groups (favorable, intermediate-I, intermediate-II, and adverse) separately for 354 patients age < 60 years and 110 patients age ≥ 60 years. In this modified version of ELN classification, patients with normal cytogenetic were classified by FLT3-ITD mutational status: favorable risk if FLT3-ITDwild and intermediate-I if FLT3-ITDmut. The best outcomes occurred in the ELN favorable and intermediate-II groups in younger AML patients and in the favorable and intermediate-I groups in older AML patients. Older AML patients had worse transplant outcomes within each modified ELN risk group except intermediate-I when compared with younger patients; leukemia-free survival at 3 years was 67.8% versus 49.8% in favorable, 53.4% versus 50.7% in intermediate-I, 65.7% versus 20.2% in intermediate-II, and 44.6% versus 23.8% in adverse group younger and older patients, respectively. Among lesion-specific abnormalities, del5q/-5 and abnl(17p) had the worse transplant outcomes, with 3-year leukemia-free survival rates of 18.4% and 20% in younger CR1 patients. In conclusion, the modified ELN prognostic classification developed for chemotherapy outcomes also identifies prognostic groups for HSCT, which is useful for a selection of patients for post-transplant strategies to improve outcomes.
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- 2015
44. Outcomes of Patients With Chronic Lymphocytic Leukemia and Richter's Transformation After Transplantation Failure
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Rozovski, Uri, Benjamini, Ohad, Jain, Preetesh, Thompson, Philip A, Wierda, William G, O'Brien, Susan, Burger, Jan A, Ferrajoli, Alessandra, Faderl, Stefan, Shpall, Elizabeth, Hosing, Chitra, Khouri, Issa F, Champlin, Richard, Keating, Michael J, and Estrov, Zeev
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Oncology and Carcinogenesis ,Genetics ,Cancer ,Transplantation ,Hematology ,Rare Diseases ,Orphan Drug ,Clinical Research ,Lymphoma ,Adenine ,Adult ,Aged ,Antineoplastic Agents ,Chronic Disease ,Disease Progression ,Factor Analysis ,Statistical ,Female ,Graft vs Host Disease ,Humans ,Kaplan-Meier Estimate ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Male ,Middle Aged ,Piperidines ,Pyrazoles ,Pyrimidines ,Recurrence ,Retrospective Studies ,Risk Factors ,Salvage Therapy ,Stem Cell Transplantation ,Transplantation Conditioning ,Transplantation ,Homologous ,Treatment Failure ,Treatment Outcome ,Clinical Sciences ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
PurposeAllogeneic stem-cell transplantation (SCT) induces long-term remission in a fraction of patients with high-risk chronic lymphocytic leukemia (CLL) or Richter's transformation (RT). Our purpose was to determine the outcomes of patients whose disease progressed after allogeneic SCT.Patients and methodsWe retrospectively analyzed the outcomes of 72 patients (52 with CLL and 20 with RT) who underwent allogeneic SCT between 1998 and 2011 and had documented progression after transplantation. Twenty-two (31%) never had a response, and 50 (69%) had a response but experienced relapse after a median of 7 months (range, 2 to 85 months). Forty-eight patients who were receiving or were candidates to receive post-SCT cell-based therapies were not included in this analysis.ResultsThe median age at time of transplantation was 58 years (range, 30 to 72 years). Sixty-two patients (86%) received more than two treatment regimens and 37 (51%) received more than three treatment regimens before SCT. Sixty-six patients (92%) had active disease at the time of transplantation. The 2- and 5-year survival rates were 67% and 38% (patients with CLL) and 36% and 0% (patients with RT). The patients who developed acute or chronic graft-versus-host disease had a longer overall survival (OS; P = .05). In a multivariable analysis, RT or low hemoglobin at the time of SCT predicted shorter OS. Chronic graft-versus-host disease and an initial response to SCT predicted longer OS.ConclusionPatients with CLL in whom allogeneic SCT fails may have a response to and benefit from salvage therapies, and their prognosis is relatively good.
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- 2015
45. Phase II Trial of Graft-versus-Host Disease Prophylaxis with Post-Transplantation Cyclophosphamide after Reduced-Intensity Busulfan/Fludarabine Conditioning for Hematological Malignancies.
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Alousi, Amin, Brammer, Jonathan, Saliba, Rima, Andersson, Borje, Popat, Uday, Hosing, Chitra, Jones, Roy, Shpall, Elizabeth, Khouri, Issa, Qazilbash, Muzaffar, Nieto, Yago, Shah, Nina, Ahmed, Sairah, Oran, Betul, Al Atrash, Gheath, Ciurea, Stefan, Kebriaei, Partow, Chen, Julianne, Rondon, Gabriela, and Champlin, Richard
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Acute ,Chronic ,Graft-versus-host disease ,Marrow ,Stem cell transplantation ,Adolescent ,Adult ,Aged ,Allografts ,Busulfan ,Child ,Child ,Preschool ,Cyclophosphamide ,Disease-Free Survival ,Female ,Graft vs Host Disease ,Hematologic Neoplasms ,Hematopoietic Stem Cell Transplantation ,Humans ,Infant ,Male ,Middle Aged ,Prospective Studies ,Survival Rate ,Transplantation Conditioning ,Vidarabine - Abstract
Graft-versus-host disease (GVHD) prophylaxis with post-transplantation cyclophosphamide (CY) after ablative HLA-matched bone marrow (BM) transplantation has been reported to have comparable rates of acute GVHD with an apparent reduction in chronic GVHD and infections when compared to historical prophylaxis with a calcineurin-inhibitor (CNI) and methotrexate (MTX). We conducted a phase II trial of post-transplantation CY (post-CY) after reduced-intensity conditioning (RIC) using intravenous busulfan (area under the curve of 4000 micromolar minute), fludarabine (40 mg/m(2)) for 4 days, and CY 50 mg/kg on days +3 and +4 after BM or peripheral blood (PB) transplantations from matched related (MRD) or unrelated donors (MUD). MUD recipients received antithymocyte globulin (ATG); however, a later amendment removed ATG. Forty-nine patients were treated (acute myeloid leukemia/myelodysplastic syndrome, 82%). Median age was 62 years (range, 39 to 72). Fifteen patients received an MRD (9 PB/6 BM); 34 had a MUD (2 PB/32 BM). The cumulative incidence of grade II to IV acute GVHD, III to IV acute GVHD, and chronic GVHD was 58%, 22%, and 18%, respectively. A matched cohort analysis compared outcomes to tacrolimus/methotrexate GVHD prophylaxis and indicated higher rates of acute GVHD grade II to IV (46% versus 19%; hazard ratio [HR], 2.8; P = .02) and treatment-related mortality (HR, 3.3; P = .035) and worse overall survival (HR, 1.9; P = .04) with post-CY. The incidence of chronic GVHD and CMV reactivation did not differ. This study suggests that post-CY should not be used as sole GVHD prophylaxis after a RIC transplantation from HLA-matched donors.
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- 2015
46. Allogeneic stem cell transplant in patients with chronic lymphocytic leukemia with 17p deletion: consult-transplant versus consult- no-transplant analysis
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Poon, Michelle L, Fox, Patricia S, Samuels, Barry I, O’Brien, Susan, Jabbour, Elias, Hsu, Yvonne, Gulbis, Alison, Korbling, Martin, Champlin, Richard, Abruzzo, Lynne V, Bassett, Roland L, and Khouri, Issa F
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Stem Cell Research ,Cancer ,Stem Cell Research - Nonembryonic - Human ,Clinical Research ,Lymphoma ,Rare Diseases ,Hematology ,Transplantation ,Adult ,Aged ,Chromosome Deletion ,Chromosomes ,Human ,Pair 17 ,Female ,Follow-Up Studies ,Graft vs Host Disease ,Humans ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Male ,Middle Aged ,Referral and Consultation ,Retrospective Studies ,Stem Cell Transplantation ,Survival Analysis ,Survival Rate ,Time Factors ,Transplantation ,Homologous ,Treatment Outcome ,17p− ,CLL ,allogeneic transplant ,Clinical Sciences ,Immunology ,Cardiovascular medicine and haematology - Abstract
Allogeneic stem cell transplant (alloSCT) can overcome the adverse prognosis of chronic lymphocytic leukemia with 17p deletion (17p- CLL). However, its applicability remains unclear. Since 2007, our leukemia service has referred patients with 17p- CLL for alloSCT at presentation. In this study, the outcomes of these patients were reviewed retrospectively to determine whether they underwent alloSCT and why patients did not undergo alloSCT. Fifty-two patients with 17p- CLL who were referred to the transplant service from 2007 to 2010 were identified. Of these patients, 32 (62%) did not undergo alloSCT, mainly because of treatment- or disease-related complications (n = 15). The 2-year post-referral overall survival rates of the alloSCT and non-SCT groups were 64% and 25%, respectively (p = 0.001). These findings suggest that while alloSCT is an effective therapy in patients with 17p- CLL, pre-SCT complications may preclude a significant proportion of patients from undergoing the procedure.
- Published
- 2015
47. Similar transplantation outcomes for acute myeloid leukemia and myelodysplastic syndrome patients with haploidentical versus 10/10 human leukocyte antigen-matched unrelated and related donors.
- Author
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Di Stasi, Antonio, Milton, Denái, Poon, L, Hamdi, Amir, Rondon, Gabriela, Chen, Julianne, Pingali, Sai, Konopleva, Marina, Alousi, Amin, Qazilbash, Muzaffar, Ahmed, Sairah, Bashir, Qaiser, Al-atrash, Gheath, Oran, Betul, Hosing, Chitra, Kebriaei, Partow, Popat, Uday, Shpall, Elizabeth, Lee, Dean, de Lima, Marcos, Rezvani, Katayoun, Khouri, Issa, Champlin, Richard, Ciurea, Stefan, and Kongtim, Piyanuch
- Subjects
Acute myeloid leukemia ,Fludarabine-melphalan ,Haploidentical transplantation ,Hematopoietic stem cell transplantation ,Myeloablative reduced-intensity conditioning regimen ,Myelodysplastic syndromes ,Post-transplantation cyclophosphamide ,Adult ,Aged ,Allografts ,Disease-Free Survival ,Female ,HLA Antigens ,Histocompatibility Testing ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Myelodysplastic Syndromes ,Retrospective Studies ,Stem Cell Transplantation ,Survival Rate ,Unrelated Donors - Abstract
Allogeneic stem cell transplantation for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) has been performed primarily with an HLA-matched donor. Outcomes of haploidentical transplantation have recently improved, and a comparison between donor sources in a uniform cohort of patients has not been performed. We evaluated outcomes of 227 patients with AML/MDS treated with melphalan-based conditioning. Donors were matched related (MRD) (n = 87, 38%), matched unrelated (MUD) (n = 108, 48%), or haploidentical (n = 32, 14%). No significant differences were found between haploidentical and MUD transplantation outcomes; however, there was a trend for improved outcomes in the MRD group, with 3-year progression-free survival for patients in remission of 57%, 45%, and 41% for MRD, MUD, and haploidentical recipients, respectively (P = .417). Recovery of T cell subsets was similar for all groups. These results suggest that haploidentical donors can safely extend transplantation for AML/MDS patients without an HLA-matched donor. Prospective studies comparing haploidentical and MUD transplantation are warranted.
- Published
- 2014
48. Impact of Donor Type and Melphalan Dose on Allogeneic Transplantation Outcomes for Patients with Lymphoma
- Author
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Saini, Neeraj Y., Saliba, Rima M., Rondon, Gabriela, Maadani, Farzaneh, Popat, Uday, Hosing, Chitra M., Oran, Betul, Bashir, Qaiser, Olson, Amanda, Nieto, Yago, Alousi, Amin, Kebriaei, Partow, Srour, Samer, Mehta, Rohtesh, Anderlini, Paolo, Shpall, Elizabeth J., Qazilbash, Muzaffar H., Khouri, Issa F., Fayad, Luis, Lee, Hun, Fowler, Nathan, Parmar, Simrit, Westin, Jason, Hagemeister, Fredrick, Champlin, Richard E., and Ciurea, Stefan O.
- Published
- 2019
- Full Text
- View/download PDF
49. Post-Transplantation Cyclophosphamide Versus Tacrolimus and Methotrexate Graft-Versus-Host Disease Prophylaxis for HLA-Matched Donor Transplantation
- Author
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Mehta, Rohtesh S., Saliba, Rima M., Rondon, Gabriela, Al-Atrash, Gheath, Bashir, Qaiser, Hosing, Chitra M., Kebriaei, Partow, Khouri, Issa, Nieto, Yago, Oran, Betul, Popat, Uday R., Qazilbash, Muzaffar H., Ramdial, Jeremy, Srour, Samer A., Champlin, Richard E., Rezvani, Katayoun, Shpall, Elizabeth J., and Alousi, Amin M.
- Published
- 2022
- Full Text
- View/download PDF
50. Allogeneic stem cell transplantation as initial salvage for patients with acute myeloid leukemia refractory to high-dose cytarabine-based induction chemotherapy.
- Author
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Jabbour, Elias, Daver, Naval, Champlin, Richard, Mathisen, Michael, Oran, Betul, Ciurea, Stefan, Khouri, Issa, Cornelison, A, Ghanem, Hady, Cardenas-Turanzas, Marylou, Popat, Uday, Ravandi, Farhad, Giralt, Sergio, Garcia-Manero, Guillermo, Cortes, Jorge, Kantarjian, Hagop, and de Lima, Marcos
- Subjects
Adult ,Aged ,Allografts ,Antineoplastic Combined Chemotherapy Protocols ,Bone Marrow ,Cytarabine ,Disease-Free Survival ,Drug Resistance ,Neoplasm ,Hematopoietic Stem Cell Transplantation ,Humans ,Kaplan-Meier Estimate ,Leukemia ,Myeloid ,Acute ,Middle Aged ,Neoplastic Stem Cells ,Prognosis ,Proportional Hazards Models ,Remission Induction ,Retrospective Studies ,Risk Factors ,Salvage Therapy ,Transplantation Conditioning ,Treatment Outcome ,Young Adult - Abstract
Outcomes of patients with acute myeloid leukemia (AML) who are refractory to high-dose Cytarabine (HiDAC)-based induction are dismal. Allogeneic hematopoietic stem cell transplantation (AHSCT) as initial salvage may be effective and potentially superior to conventional salvage chemotherapy. Eighteen percent (285 of 1597) of AML patients were primary refractory to HiDAC-based regimens at the MD Anderson Cancer Center between 1995 and 2009. AHSCT was the initial salvage in 28 cases. These patients were compared against 149 patients who received salvage chemotherapy, but never received AHSCT. Patients receiving salvage chemotherapy were older, had higher bone marrow blasts percentage, and higher incidence of unfavorable cytogenetics (P
- Published
- 2014
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