Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking
      some of the enzymes needed for cell growth.

      PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib
      mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the complete cytogenetic response rate at 12 months in patients with
           Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous
           leukemia treated with nilotinib and imatinib mesylate.

      Secondary

        -  To assess the complete cytogenetic response rate at 6 and 24 months in these patients.

        -  To assess the major and complete molecular response rate at 6, 12, and 24 months in
           these patients.

        -  To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months
           during and for 3 years after study treatment.

        -  To assess the rate of failures and the time to failure at 12, 24, and 60 months in these
           patients.

        -  To assess compliance, toxicity, and adverse events in these patients.

        -  To understand the relationship between response, gene expression profile, biomarkers,
           and drug plasma concentrations in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral nilotinib twice daily in months 1-3, 7-9, 13-15, and 19-21 and oral
      imatinib mesylate once daily in months 4-6, 10-12, 16-18, and 22-24. Treatment continues for
      24 months in the absence of disease progression or unacceptable toxicity. Patients may be
      eligible to continue oral nilotinib and oral imatinib mesylate for up to another 36 months if
      it is in the interest of the patient.

      Blood samples and bone marrow biopsies are collected periodically for cytogenetic response by
      chromosome banding analysis and FISH analysis; real-time quantitative PCR mutational analysis
      and single nucleotide polymorphism analysis of BCR-ABL transcripts; and gene expression
      profiling and correlative biomarker studies.

      After completion of study therapy, patients are followed every 6 months for 3 years and then
      every 12 months for 5 years.
    

Intervention name(s): imatinib mesylate; nilotinib; cytogenetic analysis; fluorescence in situ hybridization; microarray analysis; mutation analysis; polymerase chain reaction; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Genetic; Genetic; Genetic; Genetic; Genetic; Genetic; Other
Intervention MeSH terms: Imatinib Mesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myelogenous leukemia, BCR-ABL1 positive; chronic phase chronic myelogenous leukemia