Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

Completed · Phase 3

Conditions studied: 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, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Alkylating Agent-Related Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Recurrent Adult Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00093470

Run by

National Cancer Institute (NCI)

People needed

144

Starts

2004-08-18

Expected to finish

2015-04-14

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 any of the criteria below:
• Within 60 days of remission (CR or MR) by peripheral blood counts following induction therapy or
• Within 60 days of discharge from the hospital following induction therapy or
• Within 60 days of discharge from the hospital following post-remission therapy or
• Within 60 days of recovery of blood counts following last dose of chemotherapy
• All of the patients below are eligible for study entry:

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program NCORP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• SCL Health Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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