Tipifarnib in Treating Patients With Acute Myeloid Leukemia 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 acute myeloid leukemia. This randomized phase III trial is studying how well tipifarnib works compared to observation alone in preventing cancer recurrence in patients with acute myeloid leukemia.
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts in Transformation
Procedure: clinical observation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 or Patients Over Age 60 in First Remission|
- Disease-free survival [ Time Frame: From randomization until relapse or death from any cause, up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From randomization until death from any cause, up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation only.
Procedure: clinical observation
I. Compare disease-free survival in patients with acute myeloid leukemia in second or subsequent complete remission or in first complete remission treated with tipifarnib as maintenance therapy vs observation alone.
I. Compare overall survival in patients treated with these regimens. II. Determine long-term safety and toxicity of tipifarnib in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to remission status (first complete remission [CR] vs > first CR) and prior treatment for the most current remission (consolidation therapy vs no therapy). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo observation only.
Patients are followed for up to 5 years.