Recruitment

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