Using bendamustine with or without cyclophosphamide to prevent GVHD in stem cell transplant patients
Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis
This study is testing whether using bendamustine alone or with cyclophosphamide can help prevent graft-versus-host disease in patients getting stem cell transplants for blood cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, cyclophosphamide, rituximab, fludarabine |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04022239 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial evaluates the safety and effectiveness of bendamustine, with or without cyclophosphamide, in preventing graft-versus-host disease (GVHD) in patients undergoing stem cell transplantation for hematologic malignancies. The study involves a dose-escalation approach where patients receive chemotherapy and total body irradiation before the transplant, followed by either bendamustine or cyclophosphamide to mitigate the risk of GVHD. The trial also assesses treatment-related mortality, overall survival, and immune reconstitution post-transplant.
Who should consider this trial
Good fit: Ideal candidates include patients with hematologic malignancies who are undergoing HLA-mismatched hematopoietic cell transplantation.
Not a fit: Patients who are pregnant, nursing, or known to be HIV positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD in patients undergoing stem cell transplants.
How similar studies have performed: Other studies have shown promise in using similar chemotherapy regimens to prevent GVHD, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Issa F Khouri — M.D. Anderson Cancer Center
- Study coordinator: Issa F. Khouri, M D
- Email: ikhouri@mdanderson.org
- Phone: 713-745-0049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.