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A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia (NCT00003659)

National Cancer Institute (NCI)
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. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.
  • Biological: filgrastim
    Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients > 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.
    • Biological: rituximab
      Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.
      • Drug: cyclophosphamide
        Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.
        • Drug: fludarabine phosphate
          Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
          Ages eligible for Study
          18 Years to 75 Years
          Genders eligible for Study
          Accepts Healthy Volunteers

          - Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine, high dose cyclophosphamide, and rituximab.

          - Survival up to 5 years

          - Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients.

          OUTLINE: This is an open label study.

          Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks for 3 or 6 courses.

          Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for 4 weeks.

          Patient are followed every 3 months until death.

          PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.

          1 locations

          United States (1)
          • Memorial Sloan-Kettering Cancer Center
            Not specified
            New York, New York, United States, 10021
          Participant Flow: Overall Study
          Intermediate or High Risk Chronic Lymphocytic Leukemia
          Serious Adverse Events
          Intermediate or High Risk Chronic Lymphocytic Leukemia
          Other Adverse Events
          Intermediate or High Risk Chronic Lymphocytic Leukemia
          31 August, 1998
          21 September, 2017
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