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โ† Trials
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Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllM.D. Anderson Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Bendamustine
  • Cyclophosphamide
  • Filgrastim-sndz
  • Fludarabine
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Where

1 site
M D Anderson Cancer Center
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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