Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children
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
Primary Purpose: Treatment
Antoine Thyss, MD
Centre Antoine Lacassagne
United States: Federal Government