TY - JOUR
T1 - BFR (bendamustine, fludarabine, and rituximab) allogeneic conditioning for chronic lymphocytic leukemia/lymphoma
T2 - Reduced myelosuppression and GVHD
AU - Khouri, Issa F.
AU - Wei, Wei
AU - Korbling, Martin
AU - Turturro, Francesco
AU - Ahmed, Sairah
AU - Alousi, Amin
AU - Anderlini, Paolo
AU - Ciurea, Stefan
AU - Jabbour, Elias
AU - Oran, Betul
AU - Popat, Uday R.
AU - Rondon, Gabriela
AU - Bassett, Roland L.
AU - Gulbis, Alison
N1 - Publisher Copyright:
© 2014 by The American Society of Hematology.
PY - 2014/10/2
Y1 - 2014/10/2
N2 - Myelosuppression, graft-versus-host disease (GVHD), and relapse remain major causes of morbidity after stem cell transplantation for relapsed lymphoma. In this phase 1/2 study, we tested the safety and efficacy of escalating doses of bendamustine (70, 90, 110, and 130 mg/m2 per day for 3 days), coupled with our historical fixed doses of fludarabine and rituximab (BFR), as a nonmyeloablative allogeneic conditioning regimen for patients with relapsed lymphoma (n 5 41) and chronic lymphocytic leukemia (CLL) (n 5 15). Ten patients entered the phase 1 study; none experienced a dose-limiting toxicity. Forty-six additional patients were then treated in the phase 2 study at the maximum dose of 130 mg/m2 per day for 3 days. The proportions of transplants from matched siblings or unrelated donors were 54% and 46%. Remarkably, 55% of patients did not experience severe neutropenia. Forty-nine patients (88%) did not require platelet transfusion. The incidence of acute grade II-IV GVHD was 11%. The 2-year rate of extensive chronic GVHD was 26%. After a median follow-up duration of 26 months (range, 6-50 months), the 2-year overall and progression-free survival rates were 90% and 75%. In conclusion, our new BFR regimen is safe and effective for relapsed CLL and lymphoma patients. This trial was registered at www.clinicaltrials.gov as #NCT00880815. (Blood. 2014;124(14):2306-2312).
AB - Myelosuppression, graft-versus-host disease (GVHD), and relapse remain major causes of morbidity after stem cell transplantation for relapsed lymphoma. In this phase 1/2 study, we tested the safety and efficacy of escalating doses of bendamustine (70, 90, 110, and 130 mg/m2 per day for 3 days), coupled with our historical fixed doses of fludarabine and rituximab (BFR), as a nonmyeloablative allogeneic conditioning regimen for patients with relapsed lymphoma (n 5 41) and chronic lymphocytic leukemia (CLL) (n 5 15). Ten patients entered the phase 1 study; none experienced a dose-limiting toxicity. Forty-six additional patients were then treated in the phase 2 study at the maximum dose of 130 mg/m2 per day for 3 days. The proportions of transplants from matched siblings or unrelated donors were 54% and 46%. Remarkably, 55% of patients did not experience severe neutropenia. Forty-nine patients (88%) did not require platelet transfusion. The incidence of acute grade II-IV GVHD was 11%. The 2-year rate of extensive chronic GVHD was 26%. After a median follow-up duration of 26 months (range, 6-50 months), the 2-year overall and progression-free survival rates were 90% and 75%. In conclusion, our new BFR regimen is safe and effective for relapsed CLL and lymphoma patients. This trial was registered at www.clinicaltrials.gov as #NCT00880815. (Blood. 2014;124(14):2306-2312).
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U2 - 10.1182/blood-2014-07-587519
DO - 10.1182/blood-2014-07-587519
M3 - Article
C2 - 25145344
AN - SCOPUS:84907683729
SN - 0006-4971
VL - 124
SP - 2306
EP - 2312
JO - Blood
JF - Blood
IS - 14
ER -