At a glance
ClinicalIndex Comparison Record- ✓Patients in first remission following primary induction failure (must have received at least two chemotherapy induction regimens)
- ✓Patients in second or subsequent remission
- ✓Patients older than 60 years in first remission
- ✓Complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies, with confirmatory bone marrow within 2 weeks prior to randomization
- ✕Acute promyelocytic leukemia (FAB M3)
- ✕Allogeneic transplant (BMT or PSCT) in current remission
- ✕Known allergy to imidazole drugs (clotrimazole, ketoconazole, miconazole, econazole, terconazole; fluconazole, voriconazole, itraconazole are allowed)
- ✕Active cardiac or pulmonary disease unless medically controlled
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Clinical Observation and Tipifarnib for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and 16 related conditions. Completed, enrolled 144 participants across 341 sites in 3 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo observation only.
Interventions
Undergo observation
Given PO