Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Patient with hematologic malignancies.

Donor: Matched sibling, matched unrelated, mismatched or haploidentical

Zubrod performance 0 to 2 or Karnofsky of at least 60.

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

Disqualifiers

Pregnant or nursing women.

Known to be HIV positive

Active and uncontrolled disease/infection

Unable or unwilling to sign consent

Trial design

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Bendamustine
  • Cyclophosphamide
  • Filgrastim-sndz
  • Fludarabine
  • Melphalan
  • Mycophenolate Mofetil
  • Rituximab
  • Tacrolimus
  • Total-Body Irradiation

Treatment groups

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator