Last updated on May 2020

Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine

Brief description of study

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 Ib component of the study will continue to evaluate the safety and efficacy of subjects who receive PT-BEN on Days +3 and +4.

Approximately, 18-36 subjects will be treated under this protocol. Approximately 20 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.

Detailed Study Description

This study will follow the standard-of-care bone marrow transplant (BMT), with the only exception being to progressively substitute post-transplant cyclophosphamide (on Days +3 and +4 after BMT) with bendamustine. Six dose levels are planned for the Phase I component of the study, consisting of a combination of sequentially reduced doses of cyclophosphamide (PT-CY) and increased doses of bendamustine (PT-BEN) initially on Day +4 after BMT, followed by the same sequential reduction and increase on Day +3. Phase I Post -Transplant Treatment Regimens include cohorts 1-3 with de-escalation of PT- CY and escalation of PT-BEN on day +4 and cohorts 4-6 with the same regimen on day +3. Interim analysis will be performed after cohort 3 and cohort 6 in Phase 1, and include preliminary comparison between treatment and control groups.

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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