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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003729
• Other study ID #: EORTC-58953
• Secondary ID: EORTC-58953
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 20, 2012
• Start date: December 1998

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• cytarabine

• fludarabine phosphate

• idarubicin

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels (Bruxelles)
Belgium	Hopital Universitaire Des Enfants Reine Fabiola	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	Montegnee
France	Centre Hospitalier Regional et Universitaire d'Angers	Angers
France	CHR de Besancon - Hopital Saint-Jacques	Besancon
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
Portugal	Hospital Escolar San Joao	Porto

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Portugal,