Actively Recruiting
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
25
Participants Needed
1
Research Sites
385 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with hematologic malignancies
- Donor can be matched sibling, matched unrelated, mismatched, or haploidentical
- Performance status Zubrod 0 to 2 or Karnofsky score at least 60
- Adequate organ function: creatinine ≤ 1.6 mg/dL and creatinine clearance ≥ 30 ml/min
- Total bilirubin less than 1.5 times upper normal limit
- SGPT less than 2.5 times upper normal limit
- Ejection fraction ≥ 40%
- Lung function (FEV1, FVC, DLCO) ≥ 40%
- Females of childbearing potential must use effective birth control during study and for 6 months after last bendamustine dose
- Males with female partners of childbearing potential must use effective birth control during study and for 3 months after last bendamustine dose
You will not qualify if you...
- Pregnant or nursing women
- Known HIV positive status
- Active and uncontrolled disease or infection
- Unable or unwilling to sign consent
- Current active liver or biliary disease except Gilbert's syndrome
- Active hepatitis B or C infection
- Unresolved treatment toxicities greater than grade 1 from prior therapies
- Patients with standard risk acute leukemia in first remission or chronic myeloid leukemia in first chronic phase during dose escalation phase
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Issa F. Khouri, M D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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