Using bendamustine with or without cyclophosphamide to prevent GVHD in stem cell transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.