Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia
NCT ID: NCT00003729
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
13 participants
INTERVENTIONAL
1998-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.
Detailed Description
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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
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Keywords
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Study Design
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TREATMENT
Interventions
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cytarabine
fludarabine phosphate
idarubicin
Eligibility Criteria
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Inclusion Criteria
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
17 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Antoine Thyss, MD
Role: STUDY_CHAIR
Centre Antoine Lacassagne
Locations
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Algemeen Ziekenhuis Middelheim
Antwerp, , Belgium
Hopital Universitaire Des Enfants Reine Fabiola
Brussels (Bruxelles), , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), , Belgium
Universitair Ziekenhuis Gent
Ghent (Gent), , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Regional de la Citadelle
Liege (Luik), , Belgium
Clinique de l'Esperance
Montegnée, , Belgium
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
CHR de Besancon - Hopital Saint-Jacques
Besançon, , France
CHU de Caen
Caen, , France
CHR de Grenoble - La Tronche
Grenoble, , France
Centre Hospitalier Regional de Lille
Lille, , France
Hopital Debrousse
Lyon, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
CHR Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Robert Debre
Paris, , France
Institut Curie - Section Medicale
Paris, , France
Hopital Jean Bernard
Poitiers, , France
Hopital Americain
Reims, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
Hopital des Enfants (Purpan Enfants)
Toulouse, , France
Hospital Escolar San Joao
Porto, , Portugal
Countries
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Other Identifiers
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EORTC-58953
Identifier Type: -
Identifier Source: secondary_id
EORTC-58953
Identifier Type: -
Identifier Source: org_study_id