Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
Status:
Recruiting
Trial end date:
2022-11-29
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety of progressively substituting day +3 and
+4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in
myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients
with hematological malignancies.
The goal of the Phase 1 component of the study is to evaluate the safety of progressively
substituting post-transplant cyclophosphamide (PT-CY) given on Days +3 and +4 with
bendamustine (PT-BEN). The Phase I component of the study has been completed.
The Phase Ib component of the study will continue to evaluate the safety and efficacy of
subjects who receive PT-BEN on Days +3 and +4 at the maximum tolerated dose determined by
Phase I. The Phase Ib component of the study is open for enrollment.
Approximately, 18-36 subjects will be treated as part of Phase I and 15 as part of Phase Ib.
Approximately 18 subjects will be used as controls, subjects that receive no PET-BEN, for
direct comparison. Total, approximately 38-56 treatment and control patients and 38-56 donor
subjects will be enrolled.