BMT with Bendamustine + Cyclophosphamide for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Emmanuel Katsanis, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Trial Summary

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

I need a stem cell transplant for my high-risk cancer but don't have a matching donor.

My cancer is in remission and is one of the specified high-risk types.

I have a family member who can donate bone marrow to me.

Exclusion Criteria

Investigator's discretion that patient's participation would not be in their best interest or unable to adhere to study requirements

My lung function is significantly reduced.

My acute leukemia is not responding to treatment or is getting worse.

Treatment Details

Interventions

• Bendamustine (Alkylating agents)
• Cyclophosphamide (Alkylating agents)

Trial Overview The trial tests replacing some doses of post-transplant cyclophosphamide (a standard drug given after bone marrow transplants) with bendamustine to see if it's safe and works well in haploidentical bone marrow transplantation for blood cancer patients.

Participant Groups

Group I: Cyclophosphamide and Bendamustine Experimental Treatment 2 Interventions

Experimental: Cyclophosphamide and Bendamustine Control: Cyclophosphamide Interventions: * Drug: Bendamustine * Drug: Cyclophosphamide

Bendamustine is already approved in Canada, Japan for the following indications:

Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona