Busulfan, Cyclophosphamide, and Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

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

Details

• Lead Sponsor: Lori Maness Harris, MD; University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed diagnosis of 1 of the following:

• Acute myeloid leukemia

• Acute lymphocytic leukemia

• Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)

• Multiple myeloma

• Myelodysplastic syndromes

• Malignant lymphoma

• Myelofibrosis

• Requirement for myeloablative conditioning regimen confirmed by attending physician

• Available donor must meet the following criteria:

• HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens

• Matched at the A, B, and DRβ1 loci

• Single HLA-A or HLA-B antigen mismatch allowed

• Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors

• Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• DLCO ≥ 50% predicted

• LVEF ≥ 45%

• Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min

• Serum total bilirubin ≤ 2.0 mg/dL

• No active uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No HIV infection

• No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy

PRIOR CONCURRENT THERAPY:

• Not specified