Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children
cytarabine
+ fludarabine phosphate
+ idarubicin
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Hopital Universitaire Des Enfants Reine Fabiola
Brussels (Bruxelles), BelgiumAcademisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), BelgiumUniversitair Ziekenhuis Gent
Ghent (Gent), Belgium