NCT00003729

Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	cytarabine
DRUG	fludarabine phosphate
DRUG	idarubicin

Timeline

• Start date: 1998-12-01
• Primary completion: 2002-04-01
• First posted: 2003-12-10
• Last updated: 2012-09-24

Locations

23 sites across 3 countries: Belgium, France, Portugal