STI571 Compared With Interferon Alfa Plus Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Biological therapies such as interferon-alfa and STI571 may interfere with the
      growth of cancer cells. It is not yet known if STI571 is more effective than interferon alfa
      plus cytarabine for chronic myelogenous leukemia.

      PURPOSE: Randomized phase III trial to compare the effectiveness of STI571 with that of
      interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic
      myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Compare the time to treatment failure and overall survival in patients with
      newly diagnosed, previously untreated, Philadelphia chromosome positive, chronic phase
      chronic myelogenous leukemia treated with STI571 vs interferon alfa combined with cytarabine.
      II. Compare the quality of life and disease and treatment related toxicities in patients
      treated with these 2 regimens. III. Compare the rate and duration of complete hematologic
      response (CHR) and major cytogenetic response (MCR) in patients treated with these 2
      regimens. IV. Compare the rate and duration of MCR and CHR attributable to crossover therapy
      in patients who crossover to receive STI571 OR interferon alfa combined with cytarabine. V.
      Compare the tolerability and safety of these regimens in these patients. VI. Determine the
      population pharmacokinetics of STI571 in these patients.

      OUTLINE: This is a randomized, open label, crossover, multicenter study. Patients are
      randomized to one of two treatment arms: Arm I: Patients receive oral STI571 once daily. Arm
      II: Patients receive interferon alfa (IFN-A) subcutaneously (SQ) daily. Gradual intrapatient
      dose escalation is performed until the target dose of IFN-A is achieved. Patients then also
      receive cytarabine SQ daily for 10 days every month. Cytarabine is discontinued when a
      complete cytogenetic response is achieved and confirmed on two consecutive occasions not more
      than 3 months apart. Both arms: Courses repeat monthly in the absence of progression to
      accelerated phase or blast crisis, or unacceptable toxicity. Patients with no complete
      hematologic response at 6 months, no major cytogenetic response at year 2, or loss of
      complete hematologic response (without progression to accelerated or blastic phase)
      discontinue treatment on the arm to which they were originally randomized and begin treatment
      on the other arm. Crossover courses repeat monthly in the absence of progression to
      accelerated phase or blast crisis, or unacceptable toxicity. Quality of life is assessed
      prior to study; monthly for the first 6 months of study; at 9, 12, 18, and 24 months; at time
      of crossover (if applicable); and at treatment discontinuation before year 2 (if applicable).
      All patients are followed every 3 months for up to 8 years.

      PROJECTED ACCRUAL: A total of 850 patients (425 per arm) will be accrued for this study.
    

Intervention name(s): recombinant interferon alfa; cytarabine; imatinib mesylate
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Interferons; Cytarabine; Interferon-alpha; Imatinib Mesylate
Primary purpose: Treatment
Keywords: chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive