CompletedPhase 3

Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

United States, Israel, Peru144 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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease-free Survival

Timeframe: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.

Trial details

NCT IDNCT00093470

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-02-20

Results submitted2015-10-13

View on ClinicalTrials.gov More Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials