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Bendamustine with or without Cyclophosphamide for GVHD Prevention in Stem Cell Transplant

This study is looking at the safety and best dose of bendamustine, with or without cyclophosphamide, to prevent graft-versus-host disease (GVHD) in patients having a stem cell transplant. GVHD happens when the new donor cells attack your body's healthy cells. The study aims to see if bendamustine can be used instead of or with cyclophosphamide after your transplant. You might be eligible if you are 18-70 years old, have a blood cancer, and meet certain health requirements. Researchers will measure side effects for up to two years to understand how well the treatments are tolerated and how they affect your recovery and survival.

Study design
This is a dose-escalation study with 25 planned participants. Patients will be assigned to one of two treatment schedules.
What's involved
You will receive several intravenous (IV) medications, including fludarabine, melphalan, and bendamustine or cyclophosphamide, around the time of your stem cell transplant. You will also undergo total body irradiation and the stem cell transplant procedure itself.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor you for adverse events for up to two years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04022239

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
M.D. Anderson Cancer Center
~25 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationBendamustineCyclophosphamideFilgrastim-sndzFludarabineMelphalan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose level (MTDL) (Phase I)
Measured over Up to 30 days
+2 more outcomes measured

Conditions

Hematopoietic and Lymphoid System Neoplasm

Explore related trials

Hematologic Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Issa F Khouri · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Issa F. Khouri, M D
[email protected]
713-745-0049
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.

What this trial measures

  • Maximum tolerated dose level (MTDL) (Phase I)Up to 30 days

    Will employ the time-to-event Bayesian optimal interval design to find the MTDL. After the trial is completed, the MTDL will be selected based on isotonic regression as specified in Yuan et al. Specifically, MTDL will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level when the isotonic estimate is lower than the target toxicity rate will be selected and the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate will be selected.

  • Dose-limiting toxicity (Phase I)Up to 100 days
  • Incidence of adverse events (Phase II)Up to 2 years

    The trial is continuously monitored for toxicity per the statistical design.