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 With Multilineage Dysplasia Following Myelodysplastic Syndrome
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 in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
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)
Adult Pure Erythroid Leukemia (M6b)
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|
|Estimated Primary Completion Date:||August 2014 (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
Other Name: 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 219 Study Locations
|Principal Investigator:||Selina Luger||ECOG-ACRIN Cancer Research Group|