Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
|Adult Acute Myeloid Leukemia Adult Acute Myeloid Leukemia in Remission||Procedure: Clinical Observation Drug: Tipifarnib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.
- Overall Survival [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]Overall survival (OS) is defined as the time from randomization to death from any cause.
|Study Start Date:||August 2004|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A (tipifarnib)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (clinical observation)
Patients undergo observation only.
Procedure: Clinical Observation
I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with acute myeloid leukemia (AML) in second or subsequent complete remission or in complete response (CR) following primary induction failure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093470
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|Study Chair:||Selina Luger, M.D.||University of Pennsylvania|