Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 32
Summary
- Conditions
- Large Cell Lymphoma
- Acute Lymphoblastic Leukemia
- Acute Myelogenous Leukemia
- Burkitt Lymphoma
- Chronic Myelogenous Leukemia
- Gray Zone Lymphoma
- High Risk Undifferentiated Acute Leukemia
- Lymphoma, Follicular
- Lymphoma, Hodgkin
- Marginal Zone Lymphoma
- Lymphoma,Non-Hodgkin
- Mantle Cell Lymphoma
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 4 years and 30 years
- Gender
- Both males and females
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 c...
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.
Tracking Information
- NCT #
- NCT02996773
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Emmanuel Katsanis, MD The University of Arizona Cancer Center