Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or 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 antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.

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

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; Methotrexate; Tacrolimus; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following myeloid malignancies:

• Chronic myelogenous leukemia meeting 1 of the following criteria:

• Chronic phase

• Accelerated phase

• Treated blast phase

• Acute myeloid leukemia meeting 1 of the following criteria:

• In remission

• In early relapse, defined as < 10% marrow blasts

• Myelodysplastic syndromes, including all risk groups

• Other myeloproliferative disorders

• HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available

PATIENT CHARACTERISTICS:

• No other disease that would severely limit life expectancy

• AST ≤ 2 times normal

• Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min

• No cardiac insufficiency requiring treatment

• No symptomatic coronary artery disease

• PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO _2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted

• HIV negative

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No post-transplantation growth factor during methotrexate administration