Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. Evaluate the safety of substituting the standard post-transplant cyclophosphamide (PT-CY) given on day +3 and +4 with post-transplant bendamustine (PT-BEN) in patients undergoing HLA-mismatched hematopoietic cell transplantation. SECONDARY OBJECTIVES: I. To evaluate treatment-related mortality. II. To assess acute and chronic graft-versus-host disease (GVHD). III. To assess overall survival, progression-free survival and relapse rates. IV. To evaluate the risk of acute cystitis. V. To evaluate immune reconstitution after transplantation. OUTLINE: This is a dose-escala…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 us…
Interventions
- ProcedureAllogeneic Hematopoietic Stem Cell Transplantation
Undergo stem cell transplantation
- DrugBendamustine
Given IV
- DrugCyclophosphamide
Given IV
- BiologicalFilgrastim-sndz
Given SC
- DrugFludarabine
Given IV
- DrugMelphalan
Given IV
- DrugMycophenolate Mofetil
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas