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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Bendamustine Hydrochloride; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Immunoglobulins; Lenograstim; Mechlorethamine; Melphalan; Mycophenolic Acid; Nitrogen Mustard Compounds; Rituximab; Tacrolimus; Vidarabine

Criteria

Inclusion Criteria:

• Patient with hematologic malignancies.

• Donor: Mismatched or haplo-identical.

• 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. Creatine clearance will be calculated using the Cockcroft-Gault equation. (at time of study entry)

• Total bilirubin less than < 1.5 x upper limit of normal (UNL). (at time of study entry)

• Serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN. (at time of study entry)

• Ejection fraction >= 40%. (at time of study entry)

• Forced expiratory volume in one second (FEV1) >= 40%. (at time of study entry)

• Forced vital capacity (FVC) >= 40%. (at time of study entry)

• Diffusion capacity of the lung for carbon monoxide (DLCO) >= 40%. (at time of study entry)

Exclusion Criteria:

• Pregnant or nursing women.

• Known to be human immunodeficiency virus (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.