Clinical trial NCT00003729: Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
Official title: Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Keywords: recurrent childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-12-10
Enrollment: 13
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Algemeen Ziekenhuis Middelheim
city: Brussels (Bruxelles)
country: Belgium
facility: Hopital Universitaire Des Enfants Reine Fabiola
city: Brussels (Bruxelles)
country: Belgium
facility: Academisch Ziekenhuis der Vrije Universiteit Brussel
city: Ghent (Gent)
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Liege (Luik)
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Montegnee
country: Belgium
facility: Clinique de l'Esperance
city: Angers
country: France
facility: Centre Hospitalier Regional et Universitaire d'Angers
city: Besancon
country: France
facility: CHR de Besancon - Hopital Saint-Jacques
city: Caen
country: France
facility: CHU de Caen
city: Grenoble
country: France
facility: CHR de Grenoble - La Tronche
city: Lille
country: France
facility: Centre Hospitalier Regional de Lille
city: Lyon
country: France
facility: Hopital Debrousse
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHR Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Robert Debre
city: Paris
country: France
facility: Institut Curie - Section Medicale
city: Poitiers
country: France
facility: Hopital Jean Bernard
city: Reims
country: France
facility: Hopital Americain
city: Strasbourg
country: France
facility: Hopital Universitaire Hautepierre
city: Toulouse
country: France
facility: Hopital des Enfants (Purpan Enfants)
city: Porto
country: Portugal
facility: Hospital Escolar San Joao
Study officials:
affiliation: Centre Antoine Lacassagne
name: Antoine Thyss, MD
role: STUDY_CHAIR
References: