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

• Disease-free survival 1 year post-transplant
• Nonrelapse mortality on day 200 post-transplant

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of 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 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 mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating older patients with acute myeloid leukemia.

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.

• Biological: therapeutic allogeneic lymphocytes
• Drug: cyclosporine
• Drug: fludarabine phosphate
• Drug: mycophenolate mofetil
• Procedure: peripheral blood stem cell transplantation
• Radiation: radiation therapy

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