Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00003729
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels (Bruxelles), Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent (Gent), Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege (Luik), Belgium
Hospital Escolar San Joao
🇵🇹Porto, Portugal
CHR de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
Hopital Debrousse
🇫🇷Lyon, France
Hopital des Enfants (Purpan Enfants)
🇫🇷Toulouse, France
CHU de Caen
🇫🇷Caen, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Hospitalier Regional de Lille
🇫🇷Lille, France
CHR Hotel Dieu
🇫🇷Nantes, France
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Hopital Robert Debre
🇫🇷Paris, France
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Hopital Americain
🇫🇷Reims, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Hopital Universitaire Des Enfants Reine Fabiola
🇧🇪Brussels (Bruxelles), Belgium
Clinique de l'Esperance
🇧🇪Montegnee, Belgium
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
CHR de Grenoble - La Tronche
🇫🇷Grenoble, France
Institut Curie - Section Medicale
🇫🇷Paris, France