Phase 3
N=144
Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
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
Bottom Line
View on ClinicalTrials.gov: NCT00093470 ↗Enrolled (actual)
144
Serious AEs
42.6%
Results posted
Nov 2015
Primary outcome: Primary: Disease-free Survival — 8.87; 5.26 months — p=0.026
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clinical Observation (Procedure); Tipifarnib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
8.87; 5.26 | 0.026 sig |
| SECONDARY Overall Survival |
16.36; 9.27 | 0.056 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients eligible to enter this study must fall into one of these categories:
- Patients in first remission following primary induction failure
- Patients must have received at least two chemotherapy induction regimens
- Patients in second or subsequent remission
- Patients > 60 years old in first remission
- Patients must be in complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies to enter the study
- Confirmatory bone marrow must be performed = = 1000/mm^3
- Platelet count >= 50,000/mm^3
- Patients must not be taking a hepatic enzyme-inducing anti-convulsant; a patient will not be eligible for the study if the patient is currently taking one of these agents and cannot be switched to a non-hepatic enzyme-inducing anti-convulsant
Data sourced from ClinicalTrials.gov (NCT00093470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.