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18 results on '"Ravandi F"'

1. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status

Author

Roboz, GJ, Ravandi, F, Wei, AH, Dombret, H, Thol, F, Voso, MT, Schuh, AC, Porkka, K, La Torre, I, Skikne, B, Zhong, J, Beach, CL, Risueno, A, Menezes, DL, Ossenkoppele, G, Dohner, H, Roboz, GJ, Ravandi, F, Wei, AH, Dombret, H, Thol, F, Voso, MT, Schuh, AC, Porkka, K, La Torre, I, Skikne, B, Zhong, J, Beach, CL, Risueno, A, Menezes, DL, Ossenkoppele, G, and Dohner, H

Abstract

Measurable residual disease (MRD) in patients with acute myeloid leukemia (AML) in remission after intensive chemotherapy is predictive of early relapse and poor survival. Postremission maintenance therapy that prolongs MRD negativity or converts MRD+ patients to MRD- status may delay or prevent relapse and improve overall survival (OS). In the phase 3 QUAZAR AML-001 trial, oral azacitidine (oral-AZA; formerly CC-486), a hypomethylating agent, significantly prolonged OS and relapse-free survival (RFS) compared with placebo in patients aged ≥55 years with AML in first remission after intensive chemotherapy who were not candidates for hematopoietic stem cell transplantation. In this trial, MRD (≥0.1% leukemic cells in bone marrow) was assessed by multiparameter flow cytometry in serial samples collected at baseline and on day 1 of every 3 cycles. As expected, baseline MRD status was significantly associated with both OS and RFS. Multivariate analyses showed oral-AZA significantly improved OS and RFS vs placebo independent of baseline MRD status. Oral-AZA treatment also extended the duration of MRD negativity by 6 months vs placebo and resulted in a higher rate of conversion from MRD+ at baseline to MRD- during treatment: 37% vs 19%, respectively. In the oral-AZA arm, 24% of MRD responders achieved MRD negativity >6 months after treatment initiation. Although presence or absence of MRD was a strong prognostic indicator of OS and RFS, there were added survival benefits with oral-AZA maintenance therapy compared with placebo, independent of patients' MRD status at baseline. Registered at clinicaltrials.gov as #NCT01757535.

Published
2022

2. Development of a distributed international patient data registry for hairy cell leukemia

Author

Andritsos, LA, Anghelina, M, Neal, J, Blachly, JS, Mathur, P, Lele, O, Dearden, C, Iyengar, S, Cross, M, Zent, CS, Rogers, KA, Epperla, N, Lozanski, G, Oakes, CC, Kraut, E, Ruppert, AS, Zhao, Q, Bhat, SA, Forconi, F, Banerji, V, Handunnetti, S, Tam, CS, Seymour, JF, Else, M, Kreitman, RJ, Saven, A, Call, T, Parikh, SA, Ravandi, F, Johnston, JB, Tiacci, E, Troussard, X, Tallman, MS, Dietrich, S, Tadmor, T, Gozzetti, A, Zinzani, PL, Robak, T, Quest, G, Demeter, J, Rai, K, Fernandez, SA, Grever, M, Andritsos, LA, Anghelina, M, Neal, J, Blachly, JS, Mathur, P, Lele, O, Dearden, C, Iyengar, S, Cross, M, Zent, CS, Rogers, KA, Epperla, N, Lozanski, G, Oakes, CC, Kraut, E, Ruppert, AS, Zhao, Q, Bhat, SA, Forconi, F, Banerji, V, Handunnetti, S, Tam, CS, Seymour, JF, Else, M, Kreitman, RJ, Saven, A, Call, T, Parikh, SA, Ravandi, F, Johnston, JB, Tiacci, E, Troussard, X, Tallman, MS, Dietrich, S, Tadmor, T, Gozzetti, A, Zinzani, PL, Robak, T, Quest, G, Demeter, J, Rai, K, Fernandez, SA, and Grever, M

Abstract

Hairy cell leukemia (HCL) is a rare lymphoproliferative disorder, comprising only 2% of all leukemias. The Hairy Cell Leukemia Foundation (HCLF) has developed a patient data registry to enable investigators to better study the clinical features, treatment outcomes, and complications of patients with HCL. This system utilizes a centralized registry architecture. Patients are enrolled at HCL Centers of Excellence (COE) or via a web-based portal. All data are de-identified, which reduces regulatory burden and increases opportunities for data access and re-use. To date, 579 patients have been enrolled in the registry. Efforts are underway to engage additional COE's to expand access to patients across the globe. This international PDR will enable researchers to study outcomes in HCL in ways not previously possible due to the rarity of the disease and will serve as a platform for future prospective research.

Published
2022

3. Consensus opinion from an international group of experts on measurable residual disease in hairy cell leukemia

Author

Ravandi, F, Kreitman, RJ, Tiacci, E, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, SA, Blachly, JS, Broccoli, A, Call, T, Chihara, D, Dearden, C, Demeter, J, Dietrich, S, Else, M, Epperla, N, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Jorgensen, J, Juliusson, G, Lauria, F, Lozanski, G, Parikh, SA, Park, JH, Polliack, A, Quest, G, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Thompson, PA, Troussard, X, Zent, CS, Zenz, T, Zinzani, PL, Woermann, B, Rai, K, Grever, M, Ravandi, F, Kreitman, RJ, Tiacci, E, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, SA, Blachly, JS, Broccoli, A, Call, T, Chihara, D, Dearden, C, Demeter, J, Dietrich, S, Else, M, Epperla, N, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Jorgensen, J, Juliusson, G, Lauria, F, Lozanski, G, Parikh, SA, Park, JH, Polliack, A, Quest, G, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Thompson, PA, Troussard, X, Zent, CS, Zenz, T, Zinzani, PL, Woermann, B, Rai, K, and Grever, M

Abstract

A significant body of literature has been generated related to the detection of measurable residual disease (MRD) at the time of achieving complete remission (CR) in patients with hairy cell leukemia (HCL). However, due to the indolent nature of the disease as well as reports suggesting long-term survival in patients treated with a single course of a nucleoside analog albeit without evidence of cure, the merits of detection of MRD and attempts to eradicate it have been debated. Studies utilizing novel strategies in the relapse setting have demonstrated the utility of achieving CR with undetectable MRD (uMRD) in prolonging the duration of remission. Several assays including immunohistochemical analysis of bone marrow specimens, multi-parameter flow cytometry and molecular assays to detect the mutant BRAF V600E gene or the consensus primer for the immunoglobulin heavy chain gene (IGH) rearrangement have been utilized with few comparative studies. Here we provide a consensus report on the available data, the potential merits of MRD assessment in the front-line and relapse settings and recommendations on future role of MRD assessment in HCL.

Published
2022

4. AML-389 Phase 1/2 Study of SEL24/MEN1703, a First-in-Class Dual PIM/FLT3 Kinase Inhibitor, in Patients With IDH1/2Mutated Acute Myeloid Leukemia: The DIAMOND-01 Trial

Author

Martinelli, G, Santoro, A, Gambacorti Passerini, C, Polo, S, Solomon, S, Mukherjee, S, Lech-Maranda, E, Levy, M, Wierzbowska, A, Calbacho-Robles, M, Marconi, G, Giannini, M, Cano, I, Minana, L, Acuna-Cruz, E, Angelosanto, N, Mughal, T, Galleu, A, Blotta, S, Ravandi, F, Montesinos, P, Polo, SV, Solomon, SR, Levy, MY, Giannini, MB, Minana, LT, Mughal, TI, Martinelli, G, Santoro, A, Gambacorti Passerini, C, Polo, S, Solomon, S, Mukherjee, S, Lech-Maranda, E, Levy, M, Wierzbowska, A, Calbacho-Robles, M, Marconi, G, Giannini, M, Cano, I, Minana, L, Acuna-Cruz, E, Angelosanto, N, Mughal, T, Galleu, A, Blotta, S, Ravandi, F, Montesinos, P, Polo, SV, Solomon, SR, Levy, MY, Giannini, MB, Minana, LT, and Mughal, TI

Abstract

Context: Mutations in the FLT3 tyrosine kinase and in IDH1/IDH2 (collectively IDHm) co-occur in up to 30% of adults with acute myeloid leukemia (AML). SEL24/MEN1703 is an orally available, first-in-class, dual PIM/FLT3 kinase inhibitor. Preliminary results from the phase 1/2 first-in-human DIAMOND-01 trial (NCT03008187) demonstrated antitumor activity of single-agent SEL24/MEN1703 in adult patients with relapsed/refractory (R/R) IDHm AML, where 3 of 8 IDHm patients responded. Objective: To report the first safety and efficacy results from an additional expansion cohort of the DIAMOND-01 trial in 20 patients with R/R IDHm AML. Design: DIAMOND-01 is a phase 1/2, open-label, multicenter study consisting of 2 parts: dose escalation and cohort expansion, including an additional expansion cohort (IDHm) that is ongoing. Patients: Patients with R/R IDHm AML and no standard therapeutic options were eligible. Intervention(s): Patients received the recommended dose of 125 mg SEL24/MEN1703 orally, once daily for 14 days over a 21-day cycle until disease progression or unacceptable toxicity. Main Outcome Measure(s): The number and frequency of adverse events (AEs; primary) and overall response rate (ORR; secondary). Results: As of 10 January 2022, 14 patients were enrolled in the IDHm cohort. Seven patients had IDH2, 1 had IDH1/2, and 4 had IDH1 mutations. Two patients had a concomitant FLT3-ITD mutation. Safety data (N=12) showed that grade ≥3 TEAEs (≥10% of patients) were pneumonia (33%) and asthenia (17%), both unrelated to the study drug. Of the 7 patients who completed ≥1 treatment cycle and had ≥1 post-baseline assessment or clear disease progression, ORR was 28.6%; 1 patient achieved a complete response with incomplete blood count recovery at cycle 3 and underwent hematopoietic stem cell transplant, and 1 patient had a partial response at cycle 4 (confirmed at cycle 7 and still on treatment). Among the 7 remaining patients, 3 discontinued before completion of cycle 1 with

Published
2022

5. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia

Author

Uy, GL, Aldoss, I, Foster, MC, Sayre, PH, Wieduwilt, MJ, Advani, AS, Godwin, JE, Arellano, ML, Sweet, KL, Emadi, A, Ravandi, F, Erba, HP, Byrne, M, Michaelis, L, Topp, MS, Vey, N, Ciceri, F, Carrabba, MG, Paolini, S, Huls, GA, Jongen - Lavrencic, Mojca, Wermke, M, Chevallier, P, Gyan, E, Récher, C, Stiff, PJ, Pettit, KM, Löwenberg, Bob, Church, SE, Anderson, E, Vadakekolathu, J, Santaguida, M, Rettig, MP, Muth, J, Curtis, T, Fehr, E, Guo, K, Zhao, J, Bakkacha, O, Jacobs, K, Tran, K, Kaminker, P, Kostova, M, Bonvini, E, Walter, RB, Davidson-Moncada, JK, Rutella, S, DiPersio, JF, Uy, GL, Aldoss, I, Foster, MC, Sayre, PH, Wieduwilt, MJ, Advani, AS, Godwin, JE, Arellano, ML, Sweet, KL, Emadi, A, Ravandi, F, Erba, HP, Byrne, M, Michaelis, L, Topp, MS, Vey, N, Ciceri, F, Carrabba, MG, Paolini, S, Huls, GA, Jongen - Lavrencic, Mojca, Wermke, M, Chevallier, P, Gyan, E, Récher, C, Stiff, PJ, Pettit, KM, Löwenberg, Bob, Church, SE, Anderson, E, Vadakekolathu, J, Santaguida, M, Rettig, MP, Muth, J, Curtis, T, Fehr, E, Guo, K, Zhao, J, Bakkacha, O, Jacobs, K, Tran, K, Kaminker, P, Kostova, M, Bonvini, E, Walter, RB, Davidson-Moncada, JK, Rutella, S, and DiPersio, JF

Published
2021

6. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase III, placebo-controlled QUAZAR AML-001 trial

Author

Roboz, GJ, Doehner, H, Pocock, C, Dombret, H, Ravandi, F, Jang, JH, Selleslag, D, Mayer, JR, Martens, UM, Liesveld, J, Bernal, T, Wang, MC, Yu, P, Shi, L, Guo, S, La Torre, I, Skikne, B, Dong, Q, Braverman, J, Nehme, SA, Beach, CL, Wei, AH, Roboz, GJ, Doehner, H, Pocock, C, Dombret, H, Ravandi, F, Jang, JH, Selleslag, D, Mayer, JR, Martens, UM, Liesveld, J, Bernal, T, Wang, MC, Yu, P, Shi, L, Guo, S, La Torre, I, Skikne, B, Dong, Q, Braverman, J, Nehme, SA, Beach, CL, and Wei, AH

Abstract

Not available.

Published
2021

7. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial

Author

Ravandi, F, Roboz, GJ, Wei, AH, Dohner, H, Pocock, C, Selleslag, D, Montesinos, P, Sayar, H, Musso, M, Figuera-Alvarez, A, Safah, H, Tse, W, Sohn, SK, Hiwase, D, Chevassut, T, Pierdomenico, F, La Torre, I, Skikne, B, Bailey, R, Zhong, J, Beach, CL, Dombret, H, Ravandi, F, Roboz, GJ, Wei, AH, Dohner, H, Pocock, C, Selleslag, D, Montesinos, P, Sayar, H, Musso, M, Figuera-Alvarez, A, Safah, H, Tse, W, Sohn, SK, Hiwase, D, Chevassut, T, Pierdomenico, F, La Torre, I, Skikne, B, Bailey, R, Zhong, J, Beach, CL, and Dombret, H

Abstract

BACKGROUND: Most older patients with acute myeloid leukemia (AML) who attain morphologic remission with intensive chemotherapy (IC) will eventually relapse and post-relapse prognosis is dismal. In the pivotal QUAZAR AML-001 trial, oral azacitidine maintenance therapy significantly prolonged overall survival by 9.9 months (P < 0.001) and relapse-free survival by 5.3 months (P < 0.001) compared with placebo in patients with AML in first remission after IC who were not candidates for transplant. Currently, the QUAZAR AML-001 trial provides the most comprehensive safety information associated with oral azacitidine maintenance therapy. Reviewed here are common adverse events (AEs) during oral azacitidine treatment in QUAZAR AML-001, and practical recommendations for AE management based on guidance from international cancer consortiums, regulatory authorities, and the authors' clinical experience treating patients in the trial. METHODS: QUAZAR AML-001 is an international, placebo-controlled randomized phase 3 study. Patients aged ≥ 55 years with AML and intermediate- or poor-risk cytogenetics at diagnosis, who had attained first complete remission (CR) or CR with incomplete blood count recovery (CRi) within 4 months before study entry, were randomized 1:1 to receive oral azacitidine 300 mg or placebo once-daily for 14 days in repeated 28-day cycles. Safety was assessed in all patients who received ≥ 1 dose of study drug. RESULTS: A total of 469 patients received oral azacitidine (n = 236) or placebo (n = 233). Median age was 68 years. Patients received a median of 12 (range 1-80) oral azacitidine treatment cycles or 6 (1-73) placebo cycles. Gastrointestinal AEs were common and typically low-grade. The most frequent grade 3-4 AEs during oral azacitidine therapy were hematologic events. AEs infrequently required permanent discontinuation of oral azacitidine (13%), suggesting they were effectively managed with use of concomitant medications and oral azacitidine dosing modifi

Published
2021

8. Hairy cell leukemia and COVID-19 adaptation of treatment guidelines

Author

Grever, M, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, S, Blachly, JS, Call, T, Cross, M, Dearden, C, Demeter, J, Dietrich, S, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Juliusson, G, Kraut, E, Kreitman, RJ, Lauria, F, Lozanski, G, Parikh, SA, Park, J, Polliack, A, Ravandi, F, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Tiacci, E, Troussard, X, Zent, C, Zenz, T, Zinzani, PL, Wormann, B, Grever, M, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, S, Blachly, JS, Call, T, Cross, M, Dearden, C, Demeter, J, Dietrich, S, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Juliusson, G, Kraut, E, Kreitman, RJ, Lauria, F, Lozanski, G, Parikh, SA, Park, J, Polliack, A, Ravandi, F, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Tiacci, E, Troussard, X, Zent, C, Zenz, T, Zinzani, PL, and Wormann, B

Abstract

Standard treatment options in classic HCL (cHCL) result in high response rates and near normal life expectancy. However, the disease itself and the recommended standard treatment are associated with profound and prolonged immunosuppression, increasing susceptibility to infections and the risk for a severe course of COVID-19. The Hairy Cell Leukemia Foundation (HCLF) has recently convened experts and discussed different clinical strategies for the management of these patients. The new recommendations adapt the 2017 consensus for the diagnosis and management with cHCL to the current COVID-19 pandemic. They underline the option of active surveillance in patients with low but stable blood counts, consider the use of targeted and non-immunosuppressive agents as first-line treatment for cHCL, and give recommendations on preventive measures against COVID-19.

Published
2021

9. Clinical practice recommendation on hematopoietic stem cell transplantation for acute myeloid leukemia patients with FLT3-internal tandem duplication: a position statement from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Author

Bazarbachi, A., Bug, G. (Gesine), Baron, F. (Frederic), Brissot, E, Ciceri, F, Abou Dalle, I., Döhner, H. (Hartmut), Esteve, J. (Jordi), Floisand, Y., Giebel, S. (Sebastian), Gilleece, M., Gorin, N.C., Jabbour, J. (Jason), Aljurf, M, Kantarjian, H. (Hagop), Kharfan-Dabaja, M., Labopin, M. (Myriam), Lanza, F. (Francesco), Malard, F, Peric, Z., Prebet, T. (Thomas), Ravandi, F, Ruggeri, A. (Annelisa), Sanz, J. (Jaime), Schmid, C. (Christoph), Shouval, R, Spyridonidis, A., Versluis, J., Vey, N. (Norbert), Savani, BN, Nagler, A. (Arnon), Mohty, M. (Mohamad), Bazarbachi, A., Bug, G. (Gesine), Baron, F. (Frederic), Brissot, E, Ciceri, F, Abou Dalle, I., Döhner, H. (Hartmut), Esteve, J. (Jordi), Floisand, Y., Giebel, S. (Sebastian), Gilleece, M., Gorin, N.C., Jabbour, J. (Jason), Aljurf, M, Kantarjian, H. (Hagop), Kharfan-Dabaja, M., Labopin, M. (Myriam), Lanza, F. (Francesco), Malard, F, Peric, Z., Prebet, T. (Thomas), Ravandi, F, Ruggeri, A. (Annelisa), Sanz, J. (Jaime), Schmid, C. (Christoph), Shouval, R, Spyridonidis, A., Versluis, J., Vey, N. (Norbert), Savani, BN, Nagler, A. (Arnon), and Mohty, M. (Mohamad)

Abstract

The FMS-like tyrosine kinase 3 (FLT3) gene is mutated in 25-30% of patients with acute myeloid leukemia (AML). Because of the poor prognosis associated with FLT3-internal tandem duplication mutated AML, allogeneic hematopoietic stem-cell transplantation (SCT) was commonly performed in first complete remission. Remarkable progress has been made in frontline treatments with the incorporation of FLT3 inhibitors and the development of highly sensitive minimal/measurable residual disease assays. Similarly, recent progress in allogeneic hematopoietic SCT includes improvement of transplant techniques, the use of haplo-identical donors in patients lacking an HLA matched donor, and the introduction of FLT3 inhibitors as post-transplant maintenance therapy. Nevertheless, current transplant strategies vary between centers and differ in terms of transplant indications based on the internal tandem duplication allelic ratio and concomitant nucleophosmin-1 mutation, as well as in terms of post-transplant maintenance/consolidation. This review generated by international leukemia or transplant experts, mostly from the European Society for Blood and Marrow Transplantation, attempts to develop a position statement on best approaches for allogeneic hematopoietic SCT for AML with FLT3-internal tandem duplication including indications for and modalities of such transplants and on the potential optimization of post-transplant maintenance with FLT inhibitors.

Published
2020
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10. Clinical practice recommendation on hematopoietic stem cell transplantation for acute myeloid leukemia patients with FLT3-internal tandem duplication: a position statement from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Author

Bazarbachi, A, Bug, G, Baron, F, Brissot, E, Ciceri, F, Abou Dalle, I, Dohner, H, Esteve, J, Floisand, Y, Giebel, S, Gilleece, M, Gorin, NC, Jabbour, E, Aljurf, M, Kantarjian, H, Kharfan-Dabaja, M, Labopin, M, Lanza, F, Malard, F, Peric, Z, Prebet, T, Ravandi, F, Ruggeri, A, Sanz, J, Schmid, C, Shouval, R, Spyridonidis, A, Versluis, Jurjen, Vey, N, Savani, BN, Nagler, A, Mohty, M, Bazarbachi, A, Bug, G, Baron, F, Brissot, E, Ciceri, F, Abou Dalle, I, Dohner, H, Esteve, J, Floisand, Y, Giebel, S, Gilleece, M, Gorin, NC, Jabbour, E, Aljurf, M, Kantarjian, H, Kharfan-Dabaja, M, Labopin, M, Lanza, F, Malard, F, Peric, Z, Prebet, T, Ravandi, F, Ruggeri, A, Sanz, J, Schmid, C, Shouval, R, Spyridonidis, A, Versluis, Jurjen, Vey, N, Savani, BN, Nagler, A, and Mohty, M

Published
2020

11. Characteristics, outcomes, prognostic factors and treatment of patients with T-cell prolymphocytic leukemia (T-PLL)

Author

Jain, P, Jain, P, Aoki, E, Keating, M, Wierda, WG, O’Brien, S, Gonzalez, GN, Ferrajoli, A, Jain, N, Thompson, PA, Jabbour, E, Kanagal-Shamanna, R, Pierce, S, Alousi, A, Hosing, C, Khouri, I, Estrov, Z, Cortes, J, Kantarjian, H, Ravandi, F, Kadia, TM, Jain, P, Jain, P, Aoki, E, Keating, M, Wierda, WG, O’Brien, S, Gonzalez, GN, Ferrajoli, A, Jain, N, Thompson, PA, Jabbour, E, Kanagal-Shamanna, R, Pierce, S, Alousi, A, Hosing, C, Khouri, I, Estrov, Z, Cortes, J, Kantarjian, H, Ravandi, F, and Kadia, TM

Published
2017

12. A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

Author

Daver, N, Daver, N, Kantarjian, H, Ravandi, F, Estey, E, Wang, X, Garcia-Manero, G, Jabbour, E, Konopleva, M, O'Brien, S, Verstovsek, S, Kadia, T, Dinardo, C, Pierce, S, Huang, X, Pemmaraju, N, Diaz-Pines-Mateo, M, Cortes, J, Borthakur, G, Daver, N, Daver, N, Kantarjian, H, Ravandi, F, Estey, E, Wang, X, Garcia-Manero, G, Jabbour, E, Konopleva, M, O'Brien, S, Verstovsek, S, Kadia, T, Dinardo, C, Pierce, S, Huang, X, Pemmaraju, N, Diaz-Pines-Mateo, M, Cortes, J, and Borthakur, G

Published
2016

13. Prolonged survival in patients >= 60 years with first relapsed/refractory acute myeloid leukemia treated with vosaroxin plus cytarabine vs placebo plus cytarabine: Results from the phase 3 VALOR study

Author

Krug, U, Krug, U, Ravandi, F, Ritchie, EK, Sayar, H, Lancet, JE, Craig, MD, Vey, N, Strickland, SA, Schiller, GJ, Jabbour, E, Erba, HP, Pigneux, A, Horst, H-A, Recher, C, Klimek, VM, Cortes, J, Roboz, GJ, Craig, AR, Fox, JA, Ward, R, Smith, JA, Acton, G, Mehta, C, Kantarjian, HM, Stuart, RK, Krug, U, Krug, U, Ravandi, F, Ritchie, EK, Sayar, H, Lancet, JE, Craig, MD, Vey, N, Strickland, SA, Schiller, GJ, Jabbour, E, Erba, HP, Pigneux, A, Horst, H-A, Recher, C, Klimek, VM, Cortes, J, Roboz, GJ, Craig, AR, Fox, JA, Ward, R, Smith, JA, Acton, G, Mehta, C, Kantarjian, HM, and Stuart, RK

Published
2015

14. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center

Author

Walter, R.B. (Roland B.), Othus, M. (Megan), Burnett, A.K. (Alan), Löwenberg, B. (Bob), Kantarjian, H. (Hagop), Ossenkoppele, G.J. (Gert), Hills, R.K. (Robert), Ravandi, F. (F.), Pabst, T. (Thomas), Evans, A. (A.), Pierce, S.R. (S. R.), Vekemans, M.-C. (M. C.), Appelbaum, F.R. (Frederick), Estey, E.H. (Elihu), Walter, R.B. (Roland B.), Othus, M. (Megan), Burnett, A.K. (Alan), Löwenberg, B. (Bob), Kantarjian, H. (Hagop), Ossenkoppele, G.J. (Gert), Hills, R.K. (Robert), Ravandi, F. (F.), Pabst, T. (Thomas), Evans, A. (A.), Pierce, S.R. (S. R.), Vekemans, M.-C. (M. C.), Appelbaum, F.R. (Frederick), and Estey, E.H. (Elihu)

Abstract

Therapeutic resistance remains the principal problem in acute myeloid leukemia (AML). We used area under receiver-operating characteristic curves (AUCs) to quantify our ability to predict therapeutic resistance in individual patients, where AUC=1.0 denotes perfect prediction and AUC=0.5 denotes a coin flip, using data from 4601 patients with newly diagnosed AML given induction therapy with 3+7 or more intense standard regimens in UK Medical Research Council/National Cancer Research Institute, Dutch-Belgian Cooperative Trial Group for Hematology/Oncology/Swiss Group for Clinical Cancer Research, US cooperative group SWOG and MD Anderson Cancer Center studies. Age, performance status, white blood cell count, secondary disease, cytogenetic risk and FLT3-ITD/NPM1 mutation status were each independently associated with failure to achieve complete remission despite no early death ('primary refractoriness'). However, the AUC of a bootstrap-corrected multivariable model predicting this outcome was only 0.78, indicating only fair predictive ability. Removal of FLT3-ITD and NPM1 information only slightly decreased the AUC (0.76). Prediction of resistance, defined as primary refractoriness or short relapse-free survival, was even more difficult. Our limited ability to forecast resistance based on routinely available pretreatment covariates provides a rationale for continued randomization between standard and new therapies and supports further examination of genetic and posttreatment data to optimize resistance prediction in AML.

Published
2015
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15. Prolonged survival in patients >= 60 years with first relapsed/refractory acute myeloid leukemia treated with vosaroxin plus cytarabine vs placebo plus cytarabine: Results from the phase 3 VALOR study

Author

Krug, U, Krug, U, Ravandi, F, Ritchie, EK, Sayar, H, Lancet, JE, Craig, MD, Vey, N, Strickland, SA, Schiller, GJ, Jabbour, E, Erba, HP, Pigneux, A, Horst, H-A, Recher, C, Klimek, VM, Cortes, J, Roboz, GJ, Craig, AR, Fox, JA, Ward, R, Smith, JA, Acton, G, Mehta, C, Kantarjian, HM, Stuart, RK, Krug, U, Krug, U, Ravandi, F, Ritchie, EK, Sayar, H, Lancet, JE, Craig, MD, Vey, N, Strickland, SA, Schiller, GJ, Jabbour, E, Erba, HP, Pigneux, A, Horst, H-A, Recher, C, Klimek, VM, Cortes, J, Roboz, GJ, Craig, AR, Fox, JA, Ward, R, Smith, JA, Acton, G, Mehta, C, Kantarjian, HM, and Stuart, RK

Published
2015

16. An Inv(16)(p13.3q24.3)-encoded CBFA2T3-GLIS2 fusion protein defines an aggressive subtype of pediatric acute megakaryoblastic leukemia

Author

Gruber, T, Larson Gedman, A, Zhang, J, Koss, C, Marada, S, Ta, H, Chen, S, Su, X, Ogden, S, Dang, J, Wu, G, Gupta, V, Andersson, A, Pounds, S, Sh, L, Easton, J, Barbato, M, Mulder, H, Manne, J, Wang, J, Rusch, M, Ranade, S, Ganti, R, Parker, M, Ma, J, Radtke, I, Ding, L, Cazzaniga, G, Biondi, A, Kornblau, S, Ravandi, F, Kantarjian, H, Nimer, S, Döhner, K, Döhner, H, Ley, T, Ballerini, P, Shurtleff, S, Tomizawa, D, Adachi, S, Hayashi, Y, Tawa, A, Shih, L, Liang, D, Rubnitz, J, Pui, C, Mardis, E, Wilson, R, Downing, J, Gruber, TA, Koss, CS, Ta, HQ, Chen, SC, Ogden, SK, Andersson, AK, Barbato, MI, Mulder, HL, Kornblau, SM, Nimer, SD, Ley, TJ, Shih, LY, Liang, DC, Rubnitz, JE, Pui, CH, Mardis, ER, Wilson, RK, Downing, JR, BIONDI, ANDREA, Gruber, T, Larson Gedman, A, Zhang, J, Koss, C, Marada, S, Ta, H, Chen, S, Su, X, Ogden, S, Dang, J, Wu, G, Gupta, V, Andersson, A, Pounds, S, Sh, L, Easton, J, Barbato, M, Mulder, H, Manne, J, Wang, J, Rusch, M, Ranade, S, Ganti, R, Parker, M, Ma, J, Radtke, I, Ding, L, Cazzaniga, G, Biondi, A, Kornblau, S, Ravandi, F, Kantarjian, H, Nimer, S, Döhner, K, Döhner, H, Ley, T, Ballerini, P, Shurtleff, S, Tomizawa, D, Adachi, S, Hayashi, Y, Tawa, A, Shih, L, Liang, D, Rubnitz, J, Pui, C, Mardis, E, Wilson, R, Downing, J, Gruber, TA, Koss, CS, Ta, HQ, Chen, SC, Ogden, SK, Andersson, AK, Barbato, MI, Mulder, HL, Kornblau, SM, Nimer, SD, Ley, TJ, Shih, LY, Liang, DC, Rubnitz, JE, Pui, CH, Mardis, ER, Wilson, RK, Downing, JR, and BIONDI, ANDREA

Abstract

To define the mutation spectrum in non-Down syndrome acute megakaryoblastic leukemia (non-DS-AMKL), we performed transcriptome sequencing on diagnostic blasts from 14 pediatric patients and validated our findings in a recurrency/validation cohort consisting of 34 pediatric and 28 adult AMKL samples. Our analysis identified a cryptic chromosome 16 inversion (inv(16)(p13.3q24.3)) in 27% of pediatric cases, which encodes a CBFA2T3-GLIS2 fusion protein. Expression of CBFA2T3-GLIS2 in Drosophila and murine hematopoietic cells induced bone morphogenic protein (BMP) signaling and resulted in a marked increase in the self-renewal capacity of hematopoietic progenitors. These data suggest that expression of CBFA2T3-GLIS2 directly contributes to leukemogenesis

Published
2012

17. Chronic myeloid leukemia 2011: successes, challenges, and strategies--proceedings of the 5th annual BCR-ABL1 positive and BCR-ABL1 negative myeloproliferative neoplasms workshop

Author

Mughal, T, Radich, J, Van Etten, R, Quintás Cardama, A, Skorski, T, Ravandi, F, Deangelo, D, GAMBACORTI PASSERINI, C, Martinelli, G, Tefferi, A, DeAngelo, D, Tefferi, A., GAMBACORTI PASSERINI, CARLO, Mughal, T, Radich, J, Van Etten, R, Quintás Cardama, A, Skorski, T, Ravandi, F, Deangelo, D, GAMBACORTI PASSERINI, C, Martinelli, G, Tefferi, A, DeAngelo, D, Tefferi, A., and GAMBACORTI PASSERINI, CARLO

Published
2011

18. Transcriptome Sequence Analysis of Pediatric Acute Megakaryoblastic Leukemia Identifies An Inv(16)(p13.3;q24.3)-Encoded CBFA2T3-GLIS2 Fusion Protein As a Recurrent Lesion in 39% of Non-Infant Cases: A Report From the St. Jude Children's Research Hospital – Washington University Pediatric Cancer Genome Project

Author

Gruber, T, Gedman, A, Ta, H, Zhang, J, Koss, C, Chen, S, Su, X, Gupta, V, Ogden, S, Andersson, A, Easton, J, Wang, J, Rusch, M, Ding, L, Cazzaniga, G, Biondi, A, Kornblau, S, Ravandi, F, Kantarjian, H, Nimer, S, Doehner, K, Doehner, H, Ley, T, Shurtleff, S, Rubnitz, J, Pui, C, Mardis, E, Wilson, R, Downing, J, Downing, J., BIONDI, ANDREA, Gruber, T, Gedman, A, Ta, H, Zhang, J, Koss, C, Chen, S, Su, X, Gupta, V, Ogden, S, Andersson, A, Easton, J, Wang, J, Rusch, M, Ding, L, Cazzaniga, G, Biondi, A, Kornblau, S, Ravandi, F, Kantarjian, H, Nimer, S, Doehner, K, Doehner, H, Ley, T, Shurtleff, S, Rubnitz, J, Pui, C, Mardis, E, Wilson, R, Downing, J, Downing, J., and BIONDI, ANDREA

Published
2011

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