Study of Haploidentical Bone Marrow Transplant with Post-Transplant Cyclophosphamide and/or Bendamustine

This is a Phase I/II, single center study 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. This study will follow the standard-of-care bone marrow transplant (BMT), with the only exception being to gradually substitute post-transplant cyclophosphamide (on day +4 after BMT) with bendamustine. Three dose levels are planned for the phase I component of the study, consisting of a combination of sequentially reduced doses of cyclophosphamide and increased doses of bendamustine (on day +4 after BMT) with the full dose cyclophosphamide on day +3 after BMT remaining unchanged. The goal of 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.

Study phase (if other): I/II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Age: 1 to 65 years old
Gender: Males and females
Diagnosis: High-risk malignancies, which require hematopeoietic stem cell transplant (HCT) but do not have an available HLA-matched (8/8) related or unrelated donor or acceptable ? 4/6 cord blood with >1.7 x 105 CD34/kg

Primary disease category: Cancer

Sponsor: UACC

Projected enrollment dates: October 2016 to April 2018

Official study title: A Phase I/II Study of Haploidentical Bone Marrow Transplant with Post-Transplant Cyclophosphamide and/or Bendamustine