Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission (NCT00093470) | Clinical Trial Compass
CompletedPhase 3
Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
United States144 participantsStarted 2004-08-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 =\< 2 weeks prior to randomization
* Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML of one of the following types prior to achievement of CR/MR
* Acute myeloblastic leukemia, minimal differentiation (French-American-British \[FAB\] M0)
* Acute myeloblastic leukemia without differentiation (FAB M1)
* Acute myeloblastic leukemia with maturation (FAB M2)
* Acute myelomonocytic leukemia (FAB M4)
* Acute monocytic leukemia (FAB M5)
* Acute erythroleukemia (FAB M6)
* Acute megakaryocytic leukemia (FAB M7)
* Refractory anemia with excess blasts in transformation (RAEB-T)
* AML by World Health Organization (WHO) criteria
* Acute myeloid leukemia with multilineage dysplasia
* Patients with acute promyelocytic leukemia (FAB M3) are not eligible
* Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet a…
What they're measuring
1
Disease-free Survival
Timeframe: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.