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Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure. SECONDARY OBJECTIVES: I. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo observation only. After completion of study treatment, patients are followed up for 5 years. ;

Study Design

Related Conditions & MeSH terms

  • 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
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Acute
  • Myelodysplastic Syndrome With Excess Blasts
  • Myelodysplastic Syndromes
  • Preleukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Syndrome
Clinical Trial Details
NCT number NCT00093470
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 3
Start date August 18, 2004
View Details
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