Last updated on June 2018

Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine

Brief description of study

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.

Detailed Study Description

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.

Control patients will be patients that have declined to participate in the main trial but will receive haploidentical BMT with the current standard of two days of PT-CY (and no PT-BEN) and will be consented for the immune monitoring studies only.

Clinical Study Identifier: NCT02996773

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Recruitment Status: Open

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