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RECRUITING
NCT04022239
PHASE1/PHASE2

Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.

Official title: Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2020-03-13

Completion Date

2027-07-31

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplantation

DRUG

Bendamustine

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim-sndz

Given SC

DRUG

Fludarabine

Given IV

DRUG

Melphalan

Given IV

DRUG

Mycophenolate Mofetil

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo TBI

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States