BMT with Bendamustine + Cyclophosphamide for Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.
What data supports the effectiveness of the drug Bendamustine combined with Cyclophosphamide for treating leukemia?
Bendamustine has shown effectiveness in treating various blood cancers, including chronic lymphocytic leukemia and non-Hodgkin's lymphoma, and has been approved by the FDA for these uses. Additionally, studies suggest that Bendamustine can work well with other cancer drugs, like Cyclophosphamide, to enhance treatment effects, especially in resistant cases.12345
Is the combination of Bendamustine and Cyclophosphamide safe for humans?
Bendamustine has been shown to be generally safe in humans, with common side effects including nausea, fatigue, vomiting, fever, diarrhea, constipation, and headache. Serious side effects are less common but can include neutropenic fever (a type of fever that occurs when white blood cell counts are low), bone pain, and renal insufficiency (kidney problems).13567
How is the drug combination of Bendamustine and Cyclophosphamide unique for treating leukemia?
The combination of Bendamustine and Cyclophosphamide for leukemia is unique because it explores the use of Bendamustine, which is typically used in lymphoma treatments, as a substitute for other drugs in conditioning regimens before bone marrow transplantation. This approach may offer different toxicity profiles and potentially improve outcomes like earlier engraftment and reduced viral reactivation compared to traditional regimens.4891011
What is the purpose of this trial?
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.
Research Team
Emmanuel Katsanis, MD
Principal Investigator
The University of Arizona Cancer Center
Eligibility Criteria
This trial is for patients with high-risk blood cancers like ALL, AML, CML, MDS, and various lymphomas who need a bone marrow transplant but don't have a fully matched donor. They must have at least one half-matched (haploidentical) related donor available and be able to consent to the study. People can't join if they have untreated brain leukemia, severe heart or liver problems, active infections or certain other health issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Evaluate the safety of substituting post-transplant cyclophosphamide with bendamustine on Days +3 and +4 after BMT
Treatment Phase Ib
Evaluate safety and efficacy of PT-BEN at maximum tolerated dose on Days +3 and +4
Follow-up
Participants are monitored for safety and effectiveness after treatment, including immune reconstitution and infection risk
Treatment Details
Interventions
- Bendamustine
- Cyclophosphamide
Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor