A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure

Inclusion Criteria:

- Morphologically confirmed acute myeloid leukemia (AML) of 1 of the following types:

- Acute myeloblastic leukemia (M0, M1, or M2)

- Acute myelomonocytic leukemia (M4)

- Acute monocytic leukemia (M5)

- Acute erythroleukemia (M6)

- Acute megakaryocytic leukemia (M7)

- Refractory anemia with excess blasts in transformation

- AML with multilineage dysplasia

- In complete remission (CR) or molecular remission (MR) by blood counts and bone
marrow studies* AND meets 1 of the following criteria:

- In first CR after primary induction failure

- Must have received at least 2 induction chemotherapy regimens

- In second or subsequent CR

- In first remission AND > 60 years of age NOTE: *Patients with CR documented by
hematologic parameters are eligible provided current bone marrow studies confirm
CR

- Patients must meet 1 of the following criteria:

- Achieved remission within the past 60 days

- Completed induction or post-remission therapy within the past 60 days

- Achieved hematologic recovery from chemotherapy within the past 60 days

- Extramedullary disease allowed if in CR and not requiring therapy

- No acute promyelocytic leukemia (FAB M3)

- Performance status:

- ECOG 0-2

- Hematopoietic:

- Absolute neutrophil count >= 1,000/mm^3

- Platelet count >= 50,000/mm^3

- Hepatic:

- Bilirubin < 2 mg/dL

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- No active hepatic disease

- Renal:

- Creatinine =< 1.5 times ULN

- No active renal disease

- Cardiovascular:

- No active uncontrolled cardiac disease

- Pulmonary:

- No active uncontrolled pulmonary disease

- No known allergy to imidazole drugs* (e.g., clotrimazole, ketoconazole, miconazole,
econazole, or terconazole)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception NOTE: * Excludes fluconazole,
voriconazole, or itraconazole

- Prior autologous stem cell transplantation allowed

- Prior allogeneic bone marrow transplantation allowed provided treatment did not take
place during the current remission

- Recovered from prior chemotherapy

- Prior consolidation chemotherapy allowed

- No concurrent hepatic enzyme-inducing anticonvulsants