Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia Adult Acute Monocytic Leukemia Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With Maturation Adult Acute Myeloid Leukemia With Minimal Differentiation Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Adult Acute Myeloid Leukemia Without Maturation Adult Acute Myelomonocytic Leukemia Adult Erythroleukemia Adult Pure Erythroid Leukemia Alkylating Agent-Related Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Recurrent Adult Acute Myeloid Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 144
Healthy volunteers: no

Brief summary:
This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure.

SECONDARY OBJECTIVES:

I. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation only.

After completion of study treatment, patients are followed up for 5 years.

Arms:
arm 1: Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo observation only.

Interventions: intervention 1: Clinical Observation intervention 2: Tipifarnib
Intervention descriptions: intervention 1: Undergo observation intervention 2: Given PO

Protocol document: