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Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children (NCT00003729)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.
  • Drug: cytarabine
    • Drug: fludarabine phosphate
      • Drug: idarubicin
        Ages eligible for Study
        up to 17 Years
        Genders eligible for Study
        Accepts Healthy Volunteers
        OBJECTIVES: I. Evaluate the complete response rate to combination fludarabine, idarubicin, and cytarabine in children with relapsed or refractory acute lymphocytic leukemia. II. Evaluate the safety and tolerance of this treatment in these patients. III. Evaluate the time to progression, disease free survival, and overall survival of these patients.

        OUTLINE: This is an open label, multicenter study. Patients receive idarubicin IV over 1 hour on days 1-3. Fludarabine IV is administered over 30 minutes on days 1-5. Cytarabine IV is administered over 4 hours on days 1-5. If partial response is obtained, patients receive a second course of treatment. Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity. Idarubicin IV is administered over 1 hour on days 1 and 2. Fludarabine IV is administered over 30 minutes, followed by cytarabine IV over 4 hours on days 1-5. Patients are followed every 3 months for 2 years or until death.

        PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 27 months.

        23 locations

        30 November, 1998
        19 September, 2012
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