1,188 results on '"Oran, Betul"'
Search Results
2. Umbilical Cord Blood Transplantation
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Rafei, Hind, primary, Mehta, Rohtesh S., additional, Oran, Betul, additional, Rezvani, Katayoun, additional, Shpall, Elizabeth J., additional, and Olson, Amanda, additional
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- 2024
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3. Allogeneic Hematopoietic Cell Transplantation in Myelodysplastic Syndrome Patients
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oran, BETuL, primary
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- 2024
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4. List of Contributors
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Rahman, Zaid Abdel, primary, Abutalib, Syed Ali, additional, Afrough, Aimaz, additional, Ahmed, Sairah, additional, Al-Juhaishi, Taha, additional, Alousi, Amin M, additional, Alsfeld, Leonard C., additional, Awan, Farrukh T., additional, Azhar, Ahsan, additional, Bashir, Qaiser, additional, Brown, Brandon Douglas, additional, Cao, Kai, additional, Champlin, Richard E., additional, Cherng, Hua-Jay J., additional, Ciurea, Stefan O., additional, Dabaja, Bouthaina, additional, Daher, May, additional, De Lima, Marcos, additional, Dillard, Christen M., additional, Fang, Penny, additional, Viña, Marcelo A. Fernández, additional, Ferreri, Christopher James, additional, Furqan, Fateeha, additional, Gagelmann, Nico, additional, Geethakumari, Praveen Ramakrishnan, additional, Ghanem, Sassine, additional, Greenbaum, Uri, additional, Gulbis, Alison M., additional, Haider, Ali, additional, Hamadani, Mehdi, additional, Handy, Victoria Wehr, additional, Hawkins, Misha C., additional, Heredia, Ella J. Ariza, additional, Hosing, Chitra, additional, Im, Jin Seon, additional, Jain, Nitin, additional, Jallouk, Andrew P, additional, Jankowski, Mika L., additional, Kale, Brandon J., additional, Kebriaei, Partow, additional, Khalil, Lana, additional, Khan, Irum, additional, Khazal, Sajad, additional, Kongtim, Piyanuch, additional, Lin, Paul, additional, Mahadeo, Kris M., additional, Malek, Alexandre E, additional, McGee, Kara, additional, Mehta, Rohtesh S., additional, Mulanovich, Victor Eduardo, additional, Munshi, Pashna N., additional, Nastoupil, Loretta J., additional, Neelapu, Sattva S, additional, Nieto, Yago, additional, Olson, Amanda, additional, Oran, Betul, additional, Otegbeye, Folashade, additional, Patel, Akshat Maneesh, additional, Patel, Krina, additional, Paul, Prince, additional, Pemmaraju, Naveen, additional, Popat, Uday R, additional, Qazilbash, Muzaffar H., additional, Rafei, Hind, additional, Ragoonanan, Dristhi S, additional, Ramdial, Jeremy L., additional, Rezvani, Katayoun, additional, Rodriguez, Ana Avila, additional, Rondón, Gabriela, additional, Saengboon, Supawee, additional, Sanchez-Petitto, Gabriela, additional, Shigle, Terri Lynn, additional, Shpall, Elizabeth J., additional, Srour, Samer A., additional, Steiner, Raphael E., additional, Stolar, Karen R., additional, Strati, Paolo, additional, Szewczyk, Nicholas A., additional, Tanner, Mark R., additional, Tang, Kevin, additional, Thall, Peter F., additional, Tummala, Sudhakar, additional, Uzoka, Chukwuemeka, additional, Wallis, Whitney D., additional, Westin, Jason R., additional, Wilson, Nathaniel R., additional, Wu, Susan, additional, Guevara, Eduardo Yepez, additional, and Zou, Jun, additional
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- 2024
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5. A randomized phase III study of pretransplant conditioning for AML/MDS with fludarabine and once daily IV busulfan ± clofarabine in allogeneic stem cell transplantation
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Andersson, Borje S, Thall, Peter F, Ma, Junsheng, Valdez, Benigno C, Bassett, Roland, Chen, Julianne, Ahmed, Sairah, Alousi, Amin, Bashir, Qaiser, Ciurea, Stefan, Gulbis, Alison, Cool, Rita, Kawedia, Jitesh, Hosing, Chitra, Kebriaei, Partow, Kornblau, Steve, Myers, Alan, Oran, Betul, Rezvani, Katayoun, Shah, Nina, Shpall, Elizabeth, Parmar, Simrit, Popat, Uday R, Nieto, Yago, and Champlin, Richard E
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Hematology ,Transplantation ,Cancer ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Bayes Theorem ,Busulfan ,Clofarabine ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Neoplasm Recurrence ,Local ,Neoplasms ,Second Primary ,Transplantation Conditioning ,Vidarabine ,Clinical Sciences ,Oncology and Carcinogenesis ,Immunology ,Cardiovascular medicine and haematology ,Oncology and carcinogenesis - Abstract
Pretransplant conditioning with Fludarabine (Flu)-Busulfan (Bu) is safe, but clofarabine (Clo) has improved antileukemic activity. Hypothesis: Flu+Clo-Bu (FCB) yields superior progression-free survival (PFS) after allogeneic transplantation. We randomized 250 AML/MDS patients aged 3-70, Karnofsky Score ≥80, with matched donors, to FCB (n = 120) or Flu-Bu (n = 130), stratifying complete remission (CR) vs. No CR, (NCR). HCT-CI scores varied, from 0 to 10. All evaluable patients engrafted. Median follow-up was 66 months (interquartile range: 58-80). Three-year relapse incidence (RI), 25% with FCB, vs. 39% with Flu-Bu (p = 0.018), offset by higher non-relapse mortality, 22.6% (95%CI: 16-30.2%) vs. 12.3% (95%CI: 6.5-19%). Three-year PFS was 52% (95%CI: 44-62%) (FCB), vs. 48% (95%CI: 41-58%) (Flu-Bu). FCB benefited CR patients less, NCR patients age ≤ 60 had 3-year 34% RI (95%CI: 19-49%) (FCB) vs. 56% (95%CI: 38-70%) after Flu-Bu (p = 0.037). NCR patients >60 years had 3-year RI 10.0% (FCB), vs. 56.0%, after Flu-Bu (p = 0.003). Bayesian regression analysis including treatment-covariate interactions showed FCB superiority in NCR patients with low HCT-CI (0-2). Serious adverse event profiles were similar for the regimens. Conditioning with FCB did not improve PFS overall, but improved disease control in NCR patients, mandating confirmatory trials. Remission status and HCT-CI should be considered when using FCB.
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- 2022
6. Donor types and outcomes of transplantation in myelofibrosis: a CIBMTR study
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Jain, Tania, Estrada-Merly, Noel, Salas, M. Queralt, Kim, Soyoung, DeVos, Jakob, Chen, Min, Fang, Xi, Kumar, Rajat, Andrade-Campos, Marcio, Elmariah, Hany, Agrawal, Vaibhav, Aljurf, Mahmoud, Bacher, Ulrike, Badar, Talha, Badawy, Sherif M., Ballen, Karen, Beitinjaneh, Amer, Bhatt, Vijaya Raj, Bredeson, Christopher, DeFilipp, Zachariah, Dholaria, Bhagirathbhai, Farhadfar, Nosha, Farhan, Shatha, Gandhi, Arpita P., Ganguly, Siddhartha, Gergis, Usama, Grunwald, Michael R., Hamad, Nada, Hamilton, Betty K., Inamoto, Yoshihiro, Iqbal, Madiha, Jamy, Omer, Juckett, Mark, Kharfan-Dabaja, Mohamed A., Krem, Maxwell M., Lad, Deepesh P., Liesveld, Jane, Al Malki, Monzr M., Malone, Adriana K., Murthy, Hemant S., Ortí, Guillermo, Patel, Sagar S., Pawarode, Attaphol, Perales, Miguel-Angel, van der Poel, Marjolein, Ringden, Olle, Rizzieri, David A., Rovó, Alicia, Savani, Bipin N., Savoie, Mary Lynn, Seo, Sachiko, Solh, Melhem, Ustun, Celalettin, Verdonck, Leo F., Wingard, John R., Wirk, Baldeep, Bejanyan, Nelli, Jones, Richard J., Nishihori, Taiga, Oran, Betul, Nakamura, Ryotaro, Scott, Bart, Saber, Wael, and Gupta, Vikas
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- 2024
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7. 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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8. 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
9. Mismatch in SIRPα, a regulatory protein in innate immunity, is associated with chronic GVHD in hematopoietic stem cell transplantation
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Saliba, Rima M, Greenbaum, Uri, Ma, Qing, Srour, Samer A, Carmazzi, Yudith, Li, Liang, Oran, Betul, Moller, Michael, Wood, Janet, Ciurea, Stefan O, Kongtim, Piyanuch, Rondon, Gabriela, Partlow, David, Li, Dan, Rezvani, Katayoun, Shpall, Elizabeth J, Cao, Kai, Champlin, Richard E, and Zou, Jun
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Clinical Research ,Regenerative Medicine ,Stem Cell Research ,Cancer ,Hematology ,Stem Cell Research - Nonembryonic - Human ,Genetics ,Transplantation ,Rare Diseases ,Aetiology ,2.1 Biological and endogenous factors ,Inflammatory and immune system ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Immunity ,Innate ,Leukemia ,Myeloid ,Acute ,Myelodysplastic Syndromes - Abstract
Recent compelling evidence showed that innate immune effector cells could recognize allogeneic grafts and prime an adaptive immune response. Signal regulatory protein α (SIRPα) is an immunoglobulin superfamily receptor that is expressed on myeloid cells; the interaction between SIRPα and its ubiquitously expressed ligand CD47 elicits an inhibitory signal that suppresses macrophage phagocytic function. Additional studies showed that donor-recipient mismatch in SIRPα variants might activate monocytic allorecognition, possibly as the result of non-self SIRPα-CD47 interaction. However, the frequency of SIRPα variation and its role in hematopoietic stem cell transplantation (HSCT) remains unexplored. We studied 350 patients with acute myeloid leukemia/myelodysplastic syndrome who underwent HLA-matched related HSCT and found that SIRPα allelic mismatches were present in 39% of transplantation pairs. SIRPα variant mismatch was associated with a significantly higher rate of chronic graft-versus-host disease (GVHD; hazard ratio [HR], 1.5; P = .03), especially de novo chronic GVHD (HR, 2.0; P = .01), after adjusting for other predictors. Those with mismatched SIRPα had a lower relapse rate (HR, 0.6; P = .05) and significantly longer relapse-free survival (RFS; HR, 0.6; P = .04). Notably, the effect of SIRPα variant mismatch on relapse protection was most pronounced early after HSCT and in patients who were not in remission at HSCT (cumulative incidence, 73% vs 54%; HR, 0.5; P = .01). These findings show that SIRPα variant mismatch is associated with HSCT outcomes, possibly owing to innate allorecognition. SIRPα variant matching could provide valuable information for donor selection and risk stratification in HSCT.
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- 2021
10. 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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11. 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
12. A simple prognostic system in patients with myelofibrosis undergoing allogeneic stem cell transplantation: a CIBMTR/EBMT analysis
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Tamari, Roni, McLornan, Donal P., Ahn, Kwang Woo, Estrada-Merly, Noel, Hernández-Boluda, Juan Carlos, Giralt, Sergio, Palmer, Jeanne, Gale, Robert Peter, DeFilipp, Zachariah, Marks, David I., van der Poel, Marjolein, Verdonck, Leo F., Battiwalla, Minoo, Diaz, Miguel Angel, Gupta, Vikas, Ali, Haris, Litzow, Mark Robert, Lazarus, Hillard M., Gergis, Usama, Bashey, Asad, Liesveld, Jane, Hashmi, Shahrukh, Pu, Jeffrey J., Beitinjaneh, Amer, Bredeson, Christopher, Rizzieri, David, Savani, Bipin N., Abid, Muhammad Bilal, Ganguly, Siddhartha, Agrawal, Vaibhav, Ulrike Bacher, Vera, Wirk, Baldeep, Jain, Tania, Cutler, Corey, Aljurf, Mahmoud, Kindwall-Keller, Tamila, Kharfan-Dabaja, Mohamed A., Hildebrandt, Gerhard C., Pawarode, Attaphol, Solh, Melhem M., Yared, Jean A., Grunwald, Michael R., Nathan, Sunita, Nishihori, Taiga, Seo, Sachiko, Scott, Bart L., Nakamura, Ryotaro, Oran, Betul, Czerw, Tomasz, Yakoub-Agha, Ibrahim, and Saber, Wael
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- 2023
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13. Impact of type of induction therapy on outcomes in older adults with AML after allogeneic stem cell transplantation
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Short, Nicholas J., Ong, Faustine, Ravandi, Farhad, Nogueras-Gonzalez, Graciela, Kadia, Tapan M., Daver, Naval, DiNardo, Courtney D., Konopleva, Marina, Borthakur, Gautam, Oran, Betul, Al-Atrash, Gheath, Mehta, Rohtesh, Jabbour, Elias J., Yilmaz, Musa, Issa, Ghayas C, Maiti, Abhishek, Champlin, Richard E, Kantarjian, Hagop, Shpall, Elizabeth J, and Popat, Uday
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- 2023
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14. 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.
- Published
- 2020
15. 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.
- Published
- 2020
16. 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
- Subjects
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
17. 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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18. Hematopoietic Cell Transplantation in the Management of Myelodysplastic Syndrome: An Evidence-Based Review from the American Society for Transplantation and Cellular Therapy Committee on Practice Guidelines
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DeFilipp, Zachariah, Ciurea, Stefan O., Cutler, Corey, Robin, Marie, Warlick, Erica D., Nakamura, Ryotaro, Brunner, Andrew M., Dholaria, Bhagirathbhai, Walker, Alison R., Kröger, Nicolaus, Bejanyan, Nelli, Atallah, Ehab, Tamari, Roni, Solh, Melhem M., Percival, Mary-Elizabeth, de Lima, Marcos, Scott, Bart, Oran, Betul, Garcia-Manero, Guillermo, Hamadani, Mehdi, Carpenter, Paul, and DeZern, Amy E.
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- 2023
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19. Germ line predisposition variants occur in myelodysplastic syndrome patients of all ages
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Feurstein, Simone, Trottier, Amy M., Estrada-Merly, Noel, Pozsgai, Matthew, McNeely, Kelsey, Drazer, Michael W., Ruhle, Brian, Sadera, Katharine, Koppayi, Ashwin L., Scott, Bart L., Oran, Betul, Nishihori, Taiga, Agrawal, Vaibhav, Saad, Ayman, Lindsley, R. Coleman, Nakamura, Ryotaro, Kim, Soyoung, Hu, Zhenhuan, Sobecks, Ronald, Spellman, Stephen, Saber, Wael, and Godley, Lucy A.
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- 2022
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20. 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
21. 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
22. Outcomes of haploidentical vs matched sibling transplantation for acute myeloid leukemia in first complete remission.
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Rashidi, Armin, Hamadani, Mehdi, Zhang, Mei-Jie, Wang, Hai-Lin, Abdel-Azim, Hisham, Aljurf, Mahmoud, Assal, Amer, Bajel, Ashish, Bashey, Asad, Battiwalla, Minoo, Beitinjaneh, Amer, Bejanyan, Nelli, Bhatt, Vijaya, Bolaños-Meade, Javier, Byrne, Michael, Cahn, Jean-Yves, Cairo, Mitchell, Ciurea, Stefan, Copelan, Edward, Cutler, Corey, Daly, Andrew, Diaz, Miguel-Angel, Farhadfar, Nosha, Gale, Robert, Ganguly, Siddhartha, Grunwald, Michael, Hahn, Theresa, Hashmi, Shahrukh, Hildebrandt, Gerhard, Holland, H, Hossain, Nasheed, Kanakry, Christopher, Kharfan-Dabaja, Mohamed, Khera, Nandita, Koc, Yener, Lazarus, Hillard, Lee, Jong-Wook, Maertens, Johan, Martino, Rodrigo, McGuirk, Joseph, Munker, Reinhold, Murthy, Hemant, Nakamura, Ryotaro, Nathan, Sunita, Nishihori, Taiga, Palmisiano, Neil, Patel, Sagar, Pidala, Joseph, Olin, Rebecca, Olsson, Richard, Oran, Betul, Ringden, Olov, Rizzieri, David, Rowe, Jacob, Savoie, Mary, Schultz, Kirk, Seo, Sachiko, Shaffer, Brian, Singh, Anurag, Solh, Melhem, Stockerl-Goldstein, Keith, Verdonck, Leo, Wagner, John, Waller, Edmund, De Lima, Marcos, Sandmaier, Brenda, Litzow, Mark, Weisdorf, Dan, Romee, Rizwan, and Saber, Wael
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Adolescent ,Adult ,Aged ,Blood Donors ,Bone Marrow Transplantation ,Calcineurin Inhibitors ,Chronic Disease ,Cyclophosphamide ,Disease-Free Survival ,Female ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Immunosuppressive Agents ,Incidence ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Recurrence ,Remission Induction ,Retrospective Studies ,Siblings ,Survival Analysis ,Transplantation Conditioning ,Transplantation ,Haploidentical ,Young Adult - Abstract
HLA-haploidentical hematopoietic cell transplantation (Haplo-HCT) using posttransplantation cyclophosphamide (PT-Cy) has improved donor availability. However, a matched sibling donor (MSD) is still considered the optimal donor. Using the Center for International Blood and Marrow Transplant Research database, we compared outcomes after Haplo-HCT vs MSD in patients with acute myeloid leukemia (AML) in first complete remission (CR1). Data from 1205 adult CR1 AML patients (2008-2015) were analyzed. A total of 336 patients underwent PT-Cy-based Haplo-HCT and 869 underwent MSD using calcineurin inhibitor-based graft-versus-host disease (GVHD) prophylaxis. The Haplo-HCT group included more reduced-intensity conditioning (65% vs 30%) and bone marrow grafts (62% vs 7%), consistent with current practice. In multivariable analysis, Haplo-HCT and MSD groups were not different with regard to overall survival (P = .15), leukemia-free survival (P = .50), nonrelapse mortality (P = .16), relapse (P = .90), or grade II-IV acute GVHD (P = .98). However, the Haplo-HCT group had a significantly lower rate of chronic GVHD (hazard ratio, 0.38; 95% confidence interval, 0.30-0.48; P < .001). Results of subgroup analyses by conditioning intensity and graft source suggested that the reduced incidence of chronic GVHD in Haplo-HCT is not limited to a specific graft source or conditioning intensity. Center effect and minimal residual disease-donor type interaction were not predictors of outcome. Our results indicate a lower rate of chronic GVHD after PT-Cy-based Haplo-HCT vs MSD using calcineurin inhibitor-based GVHD prophylaxis, but similar other outcomes, in patients with AML in CR1. Haplo-HCT is a viable alternative to MSD in these patients.
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- 2019
23. 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
24. Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial.
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Bashir, Qaiser, Thall, Peter, Milton, Denái, Fox, Patricia, Kawedia, Jitesh, Kebriaei, Partow, Shah, Nina, Patel, Krina, Andersson, Borje, Nieto, Yago, Valdez, Ben, Parmar, Simrit, Rondon, Gabriela, Delgado, Ruby, Hosing, Chitra, Popat, Uday, Oran, Betul, Ciurea, Stefan, Lin, Pei, Weber, Donna, Thomas, Sheeba, Lee, Hans, Manasanch, Elisabet, Orlowski, Robert, Williams, Loretta, Champlin, Richard, and Qazilbash, Muzaffar
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Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Busulfan ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Kaplan-Meier Estimate ,Male ,Melphalan ,Middle Aged ,Multiple Myeloma ,Neoplasm Grading ,Transplantation Conditioning ,Transplantation ,Autologous ,Treatment Outcome - Abstract
BACKGROUND: Retrospective studies suggest that conditioning therapy with busulfan plus melphalan could result in longer progression-free survival compared with melphalan alone in patients with multiple myeloma undergoing autologous haemopoietic cell transplantation (auto-HCT). We aimed to test this hypothesis in a randomised trial. METHODS: The primary objective of the study was to compare progression-free survival with conditioning of busulfan plus melphalan with melphalan alone in patients with multiple myeloma. Patients with newly diagnosed multiple myeloma who were eligible for cell transplantation, aged 70 years or younger, with at least stable disease, were randomly assigned (1:1) to treatment. Patients received either busulfan plus melphalan, with a test dose of busulfan 32 mg/m2 followed by pharmacokinetically adjusted doses on days -7, -6, -5, and -4 to achieve a target daily area under the curve (AUC) of 5000 mmol-minute and melphalan 70 mg/m2 per day on days -2 and -1 (total melphalan dose 140 mg/m2), or a melphalan dose of 200 mg/m2 on day -2. Randomisation was performed via a Clinical Trial Conduct Website at the University of Texas MD Anderson Cancer Center. The accrual is complete and final results are presented here. The study is registered with ClinicalTrials.gov, number NCT01413178. FINDINGS: Between Oct 12, 2011, and March 22, 2017, 205 patients were assessed for eligibility and randomly assigned to treatment. The primary analysis of progression-free survival was measured in 202 patients who received treatment: 104 patients in the busulfan plus melphalan group and 98 patients in the melphalan alone group. 90 days after auto-HCT, 102 (98%) of 104 patients given busulfan plus melphalan and 95 (97%) of 98 patients given melphalan alone achieved partial response or better. The median follow-up in the busulfan plus melphalan group was 22·6 months (IQR 15·2-47·1) and 20·2 months (IQR 8·8-46·6) in the melphalan alone group. Median progression-free survival was 64·7 months (32·9-64·7) with busulfan plus melphalan versus 43·5 months (19·9-not estimated) with melphalan alone (hazard ratio 0·53 [95% CI 0·30-0·91]; p=0·022). There were no treatment-related deaths by day 100 in either group. Grade 2-3 mucositis was observed in 77 (74%) of 104 patients in the busulfan plus melphalan group versus 14 (14%) of 98 patients in the melphalan alone group. INTERPRETATION: These findings, if confirmed in other ongoing studies, suggest that busulfan plus melphalan could replace melphalan alone as the conditioning regimen for auto-HCT in patients with newly diagnosed myeloma. FUNDING: This study was funded in part by the National Institutes of Health (NIH) through MD Andersons Cancer Center Support Grant (CA016672).
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- 2019
25. HLA-DP mismatch and CMV reactivation increase risk of aGVHD independently in recipients of allogeneic stem cell transplant.
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Ghobadi, Armin, Milton, Denái, Gowda, Lohith, Rondon, Gabriela, Chemaly, Roy, Hamdi, Amir, Alousi, Amin, Afrough, Aimaz, Oran, Betul, Ciurea, Stefan, Kebriaei, Partow, Popat, Uday, Qazilbash, Muzaffar, Shpall, Elizabeth, Champlin, Richard, and Bashir, Qaiser
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Allogeneic hematopoietic stem cell transplantation ,CMV ,HLA-DP ,Acute Disease ,Adult ,Aged ,Cytomegalovirus ,Cytomegalovirus Infections ,Female ,Graft vs Host Disease ,HLA-DP Antigens ,Hematopoietic Stem Cell Transplantation ,Histocompatibility Testing ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Myelodysplastic Syndromes ,Retrospective Studies ,Risk Factors ,Transplant Recipients ,Transplantation Immunology ,Transplantation ,Homologous ,Virus Activation ,Young Adult - Abstract
HLA-DP mismatched allogeneic hematopoietic stem cell transplantation (allo-HCT) is associated with increased risk of aGVHD and decreased risk of relapse with no effects on overall survival (OS). It has been proposed that CMV-reactivation induces expression of HLA-DP molecules on GVHD target tissues by releasing inflammatory cytokines. We hypothesized that the increased GVHD incidence in HLA-DP mismatched allo-SCTs correlates with recipient CMV serostatus or CMV reactivation. In addition, CMV reactivation is associated with increased risk of GVHD with an unknown mechanism. Here, we analyzed the association between HLA-DPB1 and CMV reactivation on cumulative incidence of aGVHD and relapse as well as OS in 613 patients with AML and MDS who underwent matched related or unrelated allo-HCT at MD Anderson Cancer Center from 2005 to 2011. In multivariable analysis, HLA-DPB1 mismatching was associated with increased risk of aGVHD (hazard ratio (HR): 1.53, P
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- 2019
26. 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
27. 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
28. 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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29. Impact of frontline treatment approach on outcomes in patients with secondary AML with prior hypomethylating agent exposure
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Short, Nicholas J., Venugopal, Sangeetha, Qiao, Wei, Kadia, Tapan M., Ravandi, Farhad, Macaron, Walid, Dinardo, Courtney D., Daver, Naval, Konopleva, Marina, Borthakur, Gautam, Shpall, Elizabeth J., Popat, Uday, Champlin, Richard E., Mehta, Rohtesh, Al-Atrash, Gheath, Oran, Betul, Jabbour, Elias, Garcia-Manero, Guillermo, Issa, Ghayas C., Montalban-Bravo, Guillermo, Yilmaz, Musa, Maiti, Abhishek, and Kantarjian, Hagop
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- 2022
- Full Text
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30. 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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31. Characteristics and Outcomes of Patients With Multiple Myeloma Who Developed Therapy-Related Acute Myeloid Leukemia and Myelodysplastic Syndrome After Autologous Cell Transplantation
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Yalniz, Fevzi F., Greenbaum, Uri, Pasvolsky, Oren, Milton, Denái R., Kanagal-Shamanna, Rashmi, Ramdial, Jeremy, Srour, Samer, Mehta, Rohtesh, Alousi, Amin, Popat, Uday R., Nieto, Yago, Kebriaei, Partow, Al-Atrash, Gheath, Oran, Betul, Hosing, Chitra, Ahmed, Sairah, Champlin, Richard E., Shpall, Elizabeth J., Qazilbash, Muzaffar H., and Bashir, Qaiser
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- 2024
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32. 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
33. 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
34. Allogeneic Stem Cell Transplantation for Advanced Myelodysplastic Syndrome: Comparison of Outcomes between CD34+ Selected and Unmodified Hematopoietic Stem Cell Transplantation
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Tamari, Roni, Oran, Betul, Hilden, Patrick, Maloy, Molly, Kongtim, Piyanuch, Papadopoulos, Esperanza B, Rondon, Gabriela, Jakubowski, Ann A, Andersson, Borje S, Devlin, Sean M, Ahmed, Sairah, Popat, Uday R, Ponce, Doris, Chen, Julianne, Sauter, Craig, Young, James W, de Lima, Marcos, Perales, Miguel-Angel, O'Reilly, Richard J, Giralt, Sergio A, Champlin, Richard E, and Castro-Malaspina, Hugo
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Rare Diseases ,Clinical Research ,Transplantation ,Stem Cell Research - Nonembryonic - Human ,Orphan Drug ,Stem Cell Research ,Regenerative Medicine ,Adult ,Aged ,Allografts ,Antigens ,CD34 ,Chromosome Aberrations ,Female ,Graft vs Host Disease ,Hematopoietic Stem Cell Transplantation ,Humans ,Lymphocyte Depletion ,Male ,Middle Aged ,Myelodysplastic Syndromes ,Recurrence ,Risk Assessment ,Survival Analysis ,Transplantation ,Homologous ,Treatment Outcome ,Myelodysplastic syndrome ,Allogeneic transplantation ,T cell depletion ,Unmodified ,Clinical Sciences ,Immunology ,Cardiovascular medicine and haematology - Abstract
In this study, we compared transplantation outcomes of allogeneic hematopoietic stem cell transplantation (HSCT) in patients with advanced myelodysplastic syndrome (MDS) who received a CD34+ cell-selected and those who received an unmodified allograft. This analysis initially included 181 patients, 60 who received a CD34+ cell-selected transplant and 121 who received an unmodified transplant. Owing to significant differences in disease characteristics, the analysis was limited to patients with
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- 2018
35. Pentostatin therapy for steroid-refractory acute graft versus host disease: identifying those who may benefit
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Ragon, Brittany Knick, Mehta, Rohtesh S, Gulbis, Alison M, Saliba, Rima M, Chen, Julianne, Rondon, Gabriela, Popat, Uday R, Nieto, Yago, Oran, Betul, Olson, Amanda L, Patel, Krina, Hosing, Chitra M, Qazilbash, Muzaffar H, Shah, Nina, Kebriaei, Partow, Shpall, Elizabeth J, Champlin, Richard E, and Alousi, Amin M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Rare Diseases ,Transplantation ,Clinical Research ,Cancer ,Oral and gastrointestinal ,Good Health and Well Being ,Acute Disease ,Adolescent ,Adult ,Age Factors ,Aged ,Child ,Child ,Preschool ,Female ,Gastrointestinal Diseases ,Graft vs Host Disease ,Humans ,Liver Diseases ,Male ,Middle Aged ,Patient Selection ,Pentostatin ,Prognosis ,Risk Factors ,Salvage Therapy ,Steroids ,Survival Analysis ,Young Adult ,Clinical Sciences ,Oncology and Carcinogenesis ,Immunology ,Cardiovascular medicine and haematology ,Oncology and carcinogenesis - Abstract
We report outcomes of 60 patients with steroid-refractory (SR)-aGVHD treated with pentostatin. Almost half (47%) of patients had grade 4 GVHD-22% had stage 3-4 liver GVHD and 51% had stage 3-4 lower gastrointestinal tract (LGI) GVHD. Patients received a median of 3 courses (range, 1-9) of pentostatin. Day 28 overall response rate (ORR) was 33% (n = 20) (complete response 18% (n = 11), partial response 15% (n = 9)). Non-relapse mortality was 72% (95% confidence interval (CI) 61-84%) and overall survival (OS) was 21% (95% CI 12-32%) at 18 months. On univariate analysis, age >60 years (HR 1.9, 95% CI 1.01-3.7, p = 0.045) and presence of liver GVHD (HR 1.9, 95% CI 1.9, 95% CI 1.5-3.3, p = 0.03) were significant predictors of poor OS while patients with LGI GVHD had superior OS than those without (HR 0.4, 95% CI 0.2-0.8, p = 0.01). On stratified analysis, patients
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- 2018
36. 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
37. Histologic Grade 1 Is Associated With Increased Nonrelapsed Mortality in Lower Gastrointestinal Graft Versus Host Disease
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Im, Jin S, Abraham, Susan C, Saliba, Rima M, Rondon, Gabriela, Ross, William A, Rashid, Asif, Shpall, Elizabeth J, Popat, Uday, Qazilbash, Muzaffar H, Hosing, Chitra, Oran, Betul, Shah, Nina, Tewari, Priti, Nieto, Yago, Kebriaei, Partow, Champlin, Richard E, and Alousi, Amin M
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Cancer ,Transplantation ,Digestive Diseases ,Rare Diseases ,Clinical Research ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Biopsy ,Bone Marrow Transplantation ,Chi-Square Distribution ,Child ,Child ,Preschool ,Cord Blood Stem Cell Transplantation ,Endoscopy ,Gastrointestinal ,Female ,Gastrointestinal Diseases ,Gastrointestinal Tract ,Graft vs Host Disease ,Hematologic Neoplasms ,Humans ,Kaplan-Meier Estimate ,Male ,Middle Aged ,Multivariate Analysis ,Peripheral Blood Stem Cell Transplantation ,Predictive Value of Tests ,Prognosis ,Retrospective Studies ,Risk Factors ,Severity of Illness Index ,Young Adult ,prognostic value ,histologic grade 1 ,gastrointestinal graft versus host disease ,Pathology ,Clinical sciences - Abstract
Histologic confirmation is considered a standard practice to diagnose gastrointestinal graft versus host disease (GI GVHD) and is often used in making treatment decisions. A histologic grade is often determined in cases that are diagnosed with GI GVHD. Although extensive crypt loss (histologic grade 4) is associated with high nonrelapse mortality (NRM), the prognostic value for the more common grade 1 is poorly understood. As clinical decisions are made on the degree of histologic evidence, it is important to establish its prognostic significance. Therefore, we evaluated 309 patients who underwent endoscopic biopsy for suspected GI GVHD within 6 months posttransplant between 2009 and 2012. The presence of histologic grade 1 was associated with increased NRM (hazard ratio=2.7, P=0.02) when compared with one of negative biopsy in patients with lower but not isolated upper GI GVHD. Multivariate competing-risk regression analysis confirmed the independent impact of histologic grade 1 in patients with early clinical stages of lower GI GVHD (stage 0 to 2) (hazard ratio=2.7, P=0.044). When compared with advanced histologic grades, histologic grade 1 did not lessen the adverse outcome for patients with advanced lower GI GVHD (stage 3 to 4) (cumulative incidence NRM of 84%). In conclusion, the presence of histologic grade 1 is associated with increased NRM in patients presenting with lower GI GVHD (stages 0 to 2) and is sufficient evidence for decision to initiate therapy. At the same time, histologic grade 1 does not lessen the markedly adverse impact of advanced lower GI GVHD (stage 3 to 4) and is not synonymous with "mild" GVHD.
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- 2017
38. 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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39. Clonal cytogenetic abnormalities in donor-derived cells after sex mismatched allogeneic stem cell transplantation
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Toruner, Gokce A., Thakral, Beenu, Tang, Zhenya, Tang, Guilin, Medeiros, L. Jeffrey, and Oran, Betul
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- 2021
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40. Outcomes of Second Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myeloid Leukemia
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Yalniz, Fevzi F., Saliba, Rima M., Greenbaum, Uri, Ramdial, Jeremy, Popat, Uday, Oran, Betul, Alousi, Amin, Olson, Amanda, Alatrash, Gheath, Marin, David, Rezvani, Katayoun, Hosing, Chitra, Im, Jin, Mehta, Rohtesh, Qazilbash, Muzaffar, Joseph, Jacinth Joy, Rondon, Gabriela, Kanagal-Shamanna, Rashmi, Shpall, Elizabeth, Champlin, Richard, and Kebriaei, Partow
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- 2021
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41. Standardizing Definitions of Hematopoietic Recovery, Graft Rejection, Graft Failure, Poor Graft Function, and Donor Chimerism in Allogeneic Hematopoietic Cell Transplantation: A Report on Behalf of the American Society for Transplantation and Cellular Therapy
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Kharfan-Dabaja, Mohamed A., Kumar, Ambuj, Ayala, Ernesto, Aljurf, Mahmoud, Nishihori, Taiga, Marsh, Rebecca, Burroughs, Lauri M., Majhail, Navneet, Al-Homsi, A. Samer, Al-Kadhimi, Zaid S., Bar, Merav, Bertaina, Alice, Boelens, Jaap J., Champlin, Richard, Chaudhury, Sonali, DeFilipp, Zachariah, Dholaria, Bhagirathbhai, El-Jawahri, Areej, Fanning, Suzanne, Fraint, Ellen, Gergis, Usama, Giralt, Sergio, Hamilton, Betty K., Hashmi, Shahrukh K., Horn, Biljana, Inamoto, Yoshihiro, Jacobsohn, David A, Jain, Tania, Johnston, Laura, Kanate, Abraham S., Kansagra, Ankit, Kassim, Adetola, Kean, Leslie S., Kitko, Carrie L., Knight-Perry, Jessica, Kurtzberg, Joanne, Liu, Hien, MacMillan, Margaret L., Mahmoudjafari, Zahra, Mielcarek, Marco, Mohty, Mohamad, Nagler, Arnon, Nemecek, Eneida, Olson, Timothy S., Oran, Betul, Perales, Miguel-Angel, Prockop, Susan E., Pulsipher, Michael A., Pusic, Iskra, Riches, Marcie L., Rodriguez, Cesar, Romee, Rizwan, Rondon, Gabriela, Saad, Ayman, Shah, Nina, Shaw, Peter J., Shenoy, Shalini, Sierra, Jorge, Talano, Julie, Verneris, Michael R., Veys, Paul, Wagner, John E., Savani, Bipin N., Hamadani, Mehdi, and Carpenter, Paul A.
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- 2021
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42. Acute graft-versus-host disease is the foremost cause of late nonrelapse mortality
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Ramdial, Jeremy L., Mehta, Rohtesh S., Saliba, Rima M., Alousi, Amin M., Bashir, Qaiser, Hosing, Chitra, Kebriaei, Partow, Olson, Amanda L., Oran, Betul, Qazilbash, Muzaffar H., Srour, Samer A., Andersson, Borje S., Champlin, Richard E., and Popat, Uday
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- 2021
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43. 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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44. Transplantation Outcomes of Myelofibrosis with Busulfan and Fludarabine Myeloablative Conditioning
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Joseph, Jacinth, Srour, Samer A., Milton, Denái R., Ramdial, Jeremy L., Saini, Neeraj Y., Olson, Amanda L., Bashir, Qaiser, Oran, Betul, Alousi, Amin M., Hosing, Chitra, Qazilbash, Muzaffar H., Kebriaei, Partow, Shpall, Elizabeth J., Champlin, Richard E., and Popat, Uday R.
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- 2023
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45. Hematopoietic Cell Transplantation in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia: An Evidence-Based Review from the American Society of Transplantation and Cellular Therapy
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Dholaria, Bhagirathbhai, Savani, Bipin N., Hamilton, Betty K., Oran, Betul, Liu, Hien D., Tallman, Martin S., Ciurea, Stefan Octavian, Holtzman, Noa G., II, Gordon L. Phillips, Devine, Steven M., Mannis, Gabriel, Grunwald, Michael R., Appelbaum, Frederick, Rodriguez, Cesar, El Chaer, Firas, Shah, Nina, Hashmi, Shahrukh K., Kharfan-Dabaja, Mohamed A., DeFilipp, Zachariah, Aljurf, Mahmoud, AlShaibani, AlFadel, Inamoto, Yoshihiro, Jain, Tania, Majhail, Navneet, Perales, Miguel-Angel, Mohty, Mohamad, Hamadani, Mehdi, Carpenter, Paul A., and Nagler, Arnon
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- 2021
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46. Outcome of autologous hematopoietic stem cell transplantation in refractory multiple myeloma
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Veltri, Lauren W, Milton, Denái R, Delgado, Ruby, Shah, Nina, Patel, Krina, Nieto, Yago, Kebriaei, Partow, Popat, Uday R, Parmar, Simrit, Oran, Betul, Ciurea, Stefan, Hosing, Chitra, Lee, Hans C, Manasanch, Elisabet, Orlowski, Robert Z, Shpall, Elizabeth J, Champlin, Richard E, Qazilbash, Muzaffar H, and Bashir, Qaiser
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Rare Diseases ,Regenerative Medicine ,Stem Cell Research ,Transplantation ,Clinical Research ,Cancer ,Hematology ,Adult ,Age Factors ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Cause of Death ,Cohort Studies ,Disease-Free Survival ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Immunosuppressive Agents ,Male ,Middle Aged ,Multiple Myeloma ,Multivariate Analysis ,Prognosis ,Proteasome Inhibitors ,Remission Induction ,Retrospective Studies ,Risk Assessment ,Sex Factors ,Survival Analysis ,Transplantation ,Autologous ,Treatment Failure ,Treatment Outcome ,United States ,autologous transplantation ,immunomodulatory agent ,multiple myeloma ,proteasome inhibitor ,refractory disease ,Oncology and Carcinogenesis ,Public Health and Health Services ,Oncology & Carcinogenesis - Abstract
BackgroundDespite the introduction of effective, novel agents, the outcome of patients with refractory multiple myeloma remains poor, particularly those who are refractory to both proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs). Limited data are available on the role of autologous hematopoietic stem cell transplantation in this population.MethodsPatients with refractory myeloma who underwent first autologous hematopoietic stem cell transplantation (auto-HCT) between March 2000 and October 2015 were retrospectively analyzed. Those who had primary refractory disease and those with relapsed and refractory disease were included. Disease that was refractory to at least 1 PI and at least 1 IMiD was classified as double-refractory multiple myeloma (DR-MM).ResultsIn total, 233 patients were identified, including 105 (45%) classified with DR-MM and 128 (55%) classified with nondouble-refractory myeloma (NDR-MM). At a median follow-up of 42 months for surviving patients, at least a partial response was observed in 188 patients (81%; 83 patients in the DR-MM group [79%] and 105 patients in the NDR-MM [82%]; P = .77). A near complete response or better was observed in 52 patients (22%; 25 patients in the DR-MM group [24%] and 27 patients in the NDR-MM group [21%]; P = .77). The median progression-free survival was 17.6 months (14.4 months in the DR-MM group and 18.2 months in the NDR-MM group), and the 2-year progression-free survival rate was 38% (35% in the DR-MM group and 40% in the NDR-MM group; P = .40). The median overall survival was 48 months (38.9 months in the DR-MM group and 56.6 months in the NDR-MM group), and the 2-year overall survival rate was 74% (71% in the DR-MM group and 76% in the NDR-MM group; P = .27).ConclusionsThe current findings indicate that auto-HCT is an effective and safe therapy in patients with refractory multiple myeloma, including those who are refractory to IMiDs and PIs. Cancer 2017;123:3568-75. © 2017 American Cancer Society.
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- 2017
47. Ex Vivo Mesenchymal Precursor Cell–Expanded Cord Blood Transplantation after Reduced-Intensity Conditioning Regimens Improves Time to Neutrophil Recovery
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Mehta, Rohtesh S, Saliba, Rima M, Cao, Kai, Kaur, Indreshpal, Rezvani, Katy, Chen, Julianne, Olson, Amanda, Parmar, Simrit, Shah, Nina, Marin, David, Alousi, Amin, Hosing, Chitra, Popat, Uday, Kebriaei, Partow, Champlin, Richard, de Lima, Marcos, Skerrett, Donna, Burke, Elizabeth, Shpall, Elizabeth J, and Oran, Betul
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Stem Cell Research - Umbilical Cord Blood/ Placenta ,Transplantation ,Hematology ,Stem Cell Research - Nonembryonic - Human ,Stem Cell Research ,Aged ,Allografts ,Cord Blood Stem Cell Transplantation ,Cyclophosphamide ,Female ,Graft Survival ,Hematologic Neoplasms ,Humans ,Male ,Melphalan ,Mesenchymal Stem Cell Transplantation ,Mesenchymal Stem Cells ,Middle Aged ,Neutrophils ,Transplantation Conditioning ,Vidarabine ,Whole-Body Irradiation ,Cord blood ,Engraftment ,Expansion ,Neutrophil recovery ,Reduced-intensity conditioning ,Clinical Sciences ,Immunology ,Cardiovascular medicine and haematology - Abstract
We previously showed the safety of using cord blood (CB) expanded ex vivo in cocultures with allogeneic mesenchymal precursor cells (MPC) after myeloablative conditioning with faster recovery of neutrophils and platelets compared with historical controls. Herein, we report the transplantation outcomes of 27 patients with hematologic cancers who received 1 CB unit expanded ex vivo with MPCs in addition to an unmanipulated CB (MPC group) after reduced-intensity conditioning (RIC). The results in this group were compared with 51 historical controls who received 2 unmanipulated CB units (control group). The analyses were stratified for 2 RIC treatment groups: (1) total body irradiation 200 cGy + cyclophosphamide + fludarabine) (TCF), and (2) fludarabine + melphalan (FM). Coculture of CB with MPCs led to an expansion of total nucleated cells by a median factor of 12 and of CD34+ cells by a median factor of 49. In patients in whom engraftment occurred, the median time to neutrophil engraftment was 12 days in the MPC group, as compared with 16 days in controls (P = .02). The faster neutrophil engraftment was observed in both RIC groups. The cumulative incidence of neutrophil engraftment on day 26 was 75% with expansion versus 50% without expansion in patients who received FM as the RIC regimen (P = .03). Incidence of neutrophil engraftment was comparable in MPC and control groups if treated with TCF (82% versus 79%, P = .40). Transplantation of CB units expanded with MPCs is safe and effective with faster neutrophil engraftment even after RIC regimens.
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- 2017
48. Relapse risk and survival in patients with FLT3 mutated acute myeloid leukemia undergoing stem cell transplantation.
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Gaballa, Sameh, Saliba, Rima, Oran, Betul, Brammer, Jonathan, Chen, Julianne, Rondon, Gabriela, Alousi, Amin, Kebriaei, Partow, Marin, David, Popat, Uday, Andersson, Borje, Shpall, Elizabeth, Jabbour, Elias, Daver, Naval, Andreeff, Michael, Ravandi, Farhad, Cortes, Jorge, Patel, Keyur, Champlin, Richard, and Ciurea, Stefan
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Adolescent ,Adult ,Aged ,Female ,Hematopoietic Stem Cell Transplantation ,Humans ,Leukemia ,Myeloid ,Acute ,Male ,Middle Aged ,Mutation ,Neoplasm ,Residual ,Polymerase Chain Reaction ,Preoperative Period ,Prognosis ,Recurrence ,Remission Induction ,Retrospective Studies ,Risk ,Survival Analysis ,Survival Rate ,Young Adult ,fms-Like Tyrosine Kinase 3 - Abstract
In patients with AML with FMS-like tyrosine kinase 3 (FLT3) mutations, the significance of minimal residual disease (MRD) detected by PCR before allogeneic stem cell transplantation (SCT) on outcomes after transplant remains unclear. We identified 200 patients with FLT3-AML who underwent SCT at our institution. Disease status at transplant was: first or second complete remission (CR1/CR2, n = 119), high-risk CR (third or subsequent CR, marrow hypoplasia, or incomplete count recovery) (CR-HR, n = 31), and morphological evidence of active disease (AD, n = 50). The median follow-up was 27 months, and the 2-year overall and progression-free survival were 43% and 41%, respectively. Relapse was highest in the AD group (85%) and the CR-HR FLT3 MRD positive group (72%), followed by CR-HR FLT3 MRD negative (58%), CR1/CR2 FLT3 MRD positive (39%), and lowest in the CR1/CR2 FLT3 MRD negative group (23%). On multivariate analysis, independent factors influencing the risk of relapse were detectable morphological disease and FLT3 MRD by PCR pre-transplant. Factors that did not influence the relapse risk included: age, graft type, graft source, type of FLT3 mutation, or conditioning intensity. Morphologic and molecular remission status at the time of transplant were key predictors of disease relapse and survival in patients with FLT3-AML.
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- 2017
49. 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
50. 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.
- Published
- 2021
- Full Text
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