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Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
Sponsor: M.D. Anderson Cancer Center
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
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo stem cell transplantation
Bendamustine
Given IV
Cyclophosphamide
Given IV
Filgrastim-sndz
Given SC
Fludarabine
Given IV
Melphalan
Given IV
Mycophenolate Mofetil
Given PO
Rituximab
Given IV
Tacrolimus
Given IV and PO
Total-Body Irradiation
Undergo TBI
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States