Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I/II Study of Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide and/or Bendamustine
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of substituting day +4 cyclophosphamide with post-transplant bendamustine in myeloablative (MAC) or reduced intensity conditioning (RIC) haploidentical hematopoietic cell transplantation (HHCT) for advanced leukemia and lymphoma patients.
The phase I component of the study is to evaluate the safety of completely substituting the second dose of post-transplant cyclophosphamide (PT-CY) given on day +4 with bendamustine (PT-BEN).
The phase II component of the study will continue to evaluate the safety and efficacy of subjects who receive PT-CY on day +3 and PT-BEN on day +4.
Approximately, a total of 32 subjects will be treated under this protocol. Approximately 12 to 15 subjects will be used as control, subjects that receive no PT-BEN, for direct comparison.