NCT02996773

Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine

A Phase I/Ib Study of Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide and/or Bendamustine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 4 Years – 30 Years
• Healthy volunteers: Not accepted

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 has been completed. 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.

Detailed 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 were 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. An interim analysis was performed after cohort 3 was completed in Phase I and included a preliminary comparison between treatment and control groups. Phase Ib will evaluate patients treated with PT-CY on day +3 and PT-BEN on day +4. 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.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Myelodysplastic Syndromes
• Chronic Myelogenous Leukemia
• Lymphoma,Non-Hodgkin
• Lymphoma, Hodgkin
• Lymphoma, Follicular
• Marginal Zone Lymphoma
• Large Cell Lymphoma
• Mantle-Cell Lymphoma
• Gray Zone Lymphoma
• Burkitt Lymphoma
• High Risk Undifferentiated Acute Leukemia

Interventions

Type	Name	Description
DRUG	Bendamustine	After transplant, given intravenously on day +4 as part of Phase Ib.
DRUG	Cyclophosphamide	After transplant, given intravenously on day +3 as part of Phase 1b.

Timeline

• Start date: 2016-11-29
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2016-12-19
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States