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A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA (NCT00003620)

Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
  • Drug: alvocidib
    Given IV
    • FLAVO
    • flavopiridol
    • HMR 1275
    • L-868275
  • Other: laboratory biomarker analysis
    Correlative studies
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia.

    Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients.

    Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients.

    OUTLINE: This is an open label, multicenter study.

    Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

    Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

    Patients are followed every 3 months for the first year and then every 6 months for 5 years.

    1 locations

    United States (1)
    • Cancer and Leukemia Group B
      Not specified
      Chicago, Illinois, United States, 60606
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 May, 1999
    Updated:
    15 January, 2013
    Participants:
    37
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