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

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

Who can join

Ages 18 to 70 · All sexes

Inclusion Criteria:

* Patient with hematologic malignancies.
* Donor: Matched sibling, matched unrelated, mismatched or haploidentical
* Zubrod performance 0 to 2 or Karnofsky of at least 60.
* Adequate organ function at time of study entry:

  1. Creatinine less than or equal to 1.6 mg/dL and creatinine clearance \>/= 30 ml/min. Creatinine clearance will be calculated using the Cockcroft-Gault equation
  2. Total bilirubin less than \< 1.5 x UNL
  3. SGPT \< 2.5 x ULN
  4. Ejection fraction \>/= 40%
  5. FEV1, FVC and DLCO \>/= 40%
* Female patients of childbearing potential must agree to use an effective method of birth control while on study and for 6 months after the last dose of bendamustine. Male patients with female partners of childbearing potential must agree to use an effective method of birth control while on study and for 3 months after the last dose of bendamustine.

Exclusion Criteria:

* Pregnant or nursing women.
* Known to be HIV positive
* Active and uncontrolled disease/infection
* Unable or unwilling to sign consent
* Current active hepatic or biliary disease (with exception of Gilbert's syndrome)
* Active hepatitis B or C.
* Toxicities (grade \> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.
* Patients with standard risk acute leukemia in first complete remission and patients with chronic myeloid leukemia in first chronic will be excluded during escalated phase.

About the study

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.

What is being tested

• Allogeneic Hematopoietic Stem Cell Transplantation (procedure)
• Bendamustine (drug)
• Cyclophosphamide (drug)
• Filgrastim-sndz (biological)
• Fludarabine (drug)
• Melphalan (drug)

Sponsor: M.D. Anderson Cancer Center · Participants: 25 · Started: Mar 13, 2020

Contact the study team

• Issa F. Khouri, M D · Phone: 713-745-0049

Official record on ClinicalTrials.gov — NCT04022239

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.