• Disease-free survival 1 year post-transplant [ Designated as safety issue: No ]
  
• Nonrelapse mortality on day 200 post-transplant [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine whether a 1-year disease-free survival of at least 35% can be achieved among older patients with de novo or secondary acute myeloid leukemia in first complete remission treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation.
• Determine whether a day 200 nonrelapse-related mortality of less than 15% can be achieved among patients treated with this regimen.

Secondary

• Determine the 1-year overall survival, incidence of relapse, and incidence of graft rejection in patients treated with this regimen.
• Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell infusion on day 0. Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper on days 57-77 and oral mycophenolate mofetil twice daily on days 0-27.

After completion of study therapy, patients are followed at approximately 1, 4, 10, and 16 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

• Diagnosis of de novo acute myeloid leukemia (AML) (FAB M0-M2, M4-M7) OR secondary AML in first complete remission after prior induction chemotherapy and 1 or 2 courses of prior consolidation chemotherapy
• Transplantation conditioning must occur within 6 months of diagnosis
• No circulating leukemic blasts in peripheral blood confirmed by standard pathology
• No involvement of CNS by positive cytospin of cerebrospinal fluid

• Availability of a related donor who is genotypically or phenotypically identical

  • No identical twins

PATIENT CHARACTERISTICS:

Age

• 55 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No fulminant liver failure
• No alcoholic hepatitis
• No hepatic encephalopathy
• No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of PT
• No ascites related to portal hypertension
• No cirrhosis with evidence of portal hypertension
• No bacterial or fungal liver abscess
• No chronic viral hepatitis
• No biliary obstruction
• No symptomatic biliary disease
• Bilirubin ≤ 3 mg/dL

Renal

• Not specified

Cardiovascular

• Cardiac ejection fraction at least 40%

Pulmonary

• DLCO corrected at least 40%
• No requirement for supplemental oxygen
• Pulmonary nodules allowed if approved by the principal investigator

Other

• HIV negative
• No fungal infections with radiographic progression after treatment with amphotericin B or active triazole for more than 1 month
• No esophageal varices
• No history of bleeding esophageal varices
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 1 year after study participation
• No active or history of non-hematologic malignancies except nonmelanoma skin cancer unless in complete remission within the past 5 years and at ≤ 20% risk for recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent growth factors on days 0-27 of study therapy

Chemotherapy

• See Disease Characteristics
• More than 3 weeks since chemotherapy and prior to nonmyeloablative transplant conditioning

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified