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A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-cell CLL (NCT00003829)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Alternating treatment with more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine alternating with cyclophosphamide in treating patients who have previously untreated chronic lymphocytic leukemia.
  • Drug: cyclophosphamide
    • Drug: fludarabine phosphate
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the rate and duration of complete and partial remissions in patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with alternating courses of fludarabine and cyclophosphamide. II. Monitor and assess toxicity of this regimen in these patients. III. Utilize molecular genetic studies and flow cytometry on peripheral blood cells from patients achieving complete remission by conventional criteria. IV. Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for time to progression and overall survival of these patients.

      OUTLINE: Patients receive alternating courses of fludarabine and cyclophosphamide. Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1, 3, and 5. Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2, 4, and 6. Treatment repeats every 4 weeks. Patients achieving clinical complete remission (CCR) after 6 courses of chemotherapy receive 2 additional courses (one course of each drug). Patients achieving partial remission after 6 courses of chemotherapy also receive 2 additional courses. If these patients then achieve CCR, they receive another 2 courses. Patients are followed every 3 months.

      17 locations

      United States (17)
      • CCOP - Scottsdale Oncology Program
        Scottsdale, Arizona, United States, 85259-5404
      • CCOP - Illinois Oncology Research Association
        Peoria, Illinois, United States, 61602
      • CCOP - Carle Cancer Center
        Urbana, Illinois, United States, 61801
      • CCOP - Cedar Rapids Oncology Project
        Cedar Rapids, Iowa, United States, 52403-1206
      • CCOP - Iowa Oncology Research Association
        Des Moines, Iowa, United States, 50309-1016
      • Siouxland Hematology-Oncology
        Sioux City, Iowa, United States, 51101-1733
      • CCOP - Wichita
        Wichita, Kansas, United States, 67214-3882
      • CCOP - Ann Arbor Regional
        Ann Arbor, Michigan, United States, 48106
      • CCOP - Duluth
        Duluth, Minnesota, United States, 55805
      • Mayo Clinic Cancer Center
        Rochester, Minnesota, United States, 55905
      • CentraCare Clinic
        Saint Cloud, Minnesota, United States, 56303
      • CCOP - Metro-Minnesota
        Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Missouri Valley Cancer Consortium
        Omaha, Nebraska, United States, 68131
      • Quain & Ramstad Clinic, P.C.
        Bismarck, North Dakota, United States, 58501
      • Altru Health Systems
        Grand Forks, North Dakota, United States, 58201
      • Rapid City Regional Hospital
        Rapid City, South Dakota, United States, 57709
      • CCOP - Sioux Community Cancer Consortium
        Sioux Falls, South Dakota, United States, 57105-1080
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 July, 1999
      Updated:
      04 December, 2016
      Participants:
      34
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