RecruitingPhase 1Phase 2NCT04022239

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

Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis


Sponsor

M.D. Anderson Cancer Center

Enrollment

25 participants

Start Date

Mar 13, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Allogeneic Hematopoietic Stem Cell Transplantation, a drug called Bendamustine, and others for people with hematopoietic and lymphoid system neoplasm. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplantation

DRUGBendamustine

Given IV

DRUGCyclophosphamide

Given IV

BIOLOGICALFilgrastim-sndz

Given SC

DRUGFludarabine

Given IV

DRUGMelphalan

Given IV

DRUGMycophenolate Mofetil

Given PO

BIOLOGICALRituximab

Given IV

DRUGTacrolimus

Given IV and PO

RADIATIONTotal-Body Irradiation

Undergo TBI


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04022239


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