Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
This randomized phase III trial studies 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.
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); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
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 (DFS) [ Time Frame: From randomization until relapse or death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]Comparison of DFS between treatments will be conducted using the stratified log-rank test.
- Overall survival [ Time Frame: From randomization until death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I (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 II (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 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 I: 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 II: 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
Show 221 Study Locations
|Principal Investigator:||Selina Luger||ECOG-ACRIN Cancer Research Group|