A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete
remission (CR)

- Must be at least 60 years of age if first CR

- Must have had histological proof (from bone marrow aspirate, smears, or touch
preps of marrow biopsy) of one of the following prior to achieving CR:

- Acute myeloblastic leukemia (M0, M1, M2)

- Acute promyelocytic leukemia (M3)

- Acute myelomonocytic leukemia (M4)

- Acute monocytic leukemia (M5)

- Acute erythroleukemia (M6)

- Acute megakaryocytic leukemia (M7)

- Refractory anemia with excess blasts in transformation

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 3 times upper limit of normal (ULN)

- SGOT less than 3 times ULN

Renal:

- Creatinine less than 2 mg/dL

Cardiovascular:

- No clinically significant active cardiac disease

Pulmonary:

- No clinically significant active pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No uncontrolled or active autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior autologous bone marrow transplantation (BMT) allowed

- No prior allogeneic BMT

- Other prior immunotherapy allowed if not received during the most recent treatment

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified