Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia (AML) in first morphologic complete remission

  • No FAB M3 disease
  • Preceding myelodysplastic syndromes and treatment-related AML allowed

• Morphologic complete remission achieved within the past 6 months and after no more than 2 courses of induction chemotherapy with standard cytotoxic chemotherapy (e.g., cytarabine and an anthracycline) or after no more than 4 courses of a hypomethylating agent-containing regimen including either 5-azacytidine or decitabine

  • Complete morphologic remission is defined by all of the following criteria:

    • Normal bone marrow morphology with less than 5% blasts
    • Absolute neutrophil count greater than 1,000/mm^3*
    • Platelet count greater than 100,000/mm^3*
    • No extramedullary leukemia
    • No blasts in peripheral blood NOTE: *Must be sustained for at least 30 days

• No more than 2 courses of prior consolidation therapy

  • Any consolidation regimen that does not require transplantation allowed
• No acute leukemia after blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease
• Prior CNS involvement allowed provided the disease is in remission at time of transplantation

• The following donors will be allowed:

  • Available HLA-identical (6/6) sibling donor by serological typing (A, B, DR)
  • Locus matched unrelated donor (10/10) by high resolution molecular typing (HLA-A, -B, -C, -DRB1, and -DQB1).
  • No syngeneic donors

PATIENT CHARACTERISTICS:

Age

• 60 to 74

Performance status

• 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin less than 2 mg/dL*

  • Bilirubin 2-3 mg/dL with normal direct bilirubin allowed
• AST less than 3 times upper limit of normal* NOTE: *Unless attributable to disease

Renal

• Creatinine clearance at least 40 mL/min (unless attributable to disease)

Cardiovascular

• LVEF at least 30% by MUGA or ECHO

Pulmonary

• DLCO greater than 40%
• No symptomatic pulmonary disease

Other

• Not pregnant
• Fertile patients must use effective contraception
• HIV negative
• No uncontrolled diabetes mellitus
• No active serious infection requiring antibiotics
• No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• At least 4 weeks since prior surgery