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Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia (NCT00003764)

National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously.
  • Drug: cyclophosphamide
    • Drug: fludarabine phosphate
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers

      - Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia (CLL).

      - Compare the toxicities of these 2 regimens in this patient population.

      - Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells (i.e., p53; mdm2; GST; Bcl-2; Mcl-1; Bax; p27; and caspase-3) correlates with response to chemotherapy in these patients.

      - Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression.

      - Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (O-II vs III-IV). Patients are randomized to one of two treatment arms.

      - Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.

      - Arm II: Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1.

      Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months until disease progression.

      PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study over 2 to 2.5 years.

      218 locations

      30 November, 1999
      25 January, 2010
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