Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematological Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the growth of cancer cells. Chemotherapy and antithymocyte globulin stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methotrexate after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together with busulfan, fludarabine, and antithymocyte globulin works in treating patients with hematological cancer.

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

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Antilymphocyte Serum; Busulfan; Calcium; Fludarabine; Fludarabine phosphate; Leucovorin; Levoleucovorin; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of any 1 of the following:

• Acute leukemia

• Chronic myelogenous leukemia

• Myelodysplastic syndromes

• Must have an unrelated donor available who is matched for HLA-A and -B by serology and for DRB1 by molecular typing

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Bilirubin < 3.0 mg/dL

• Creatinine < 2.0 mg/dL

• AST and ALT < 3 times the upper limit of normal

• Not pregnant or nursing

• Ejection fraction ≥ 45% by MUGA scan or ECHO

• No major illness or organ failure

• No severe psychiatric disorder or mental deficiency that makes compliance with the treatment unlikely and informed consent impossible

PRIOR CONCURRENT THERAPY:

• Not specified