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

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.

Study Overview

• Status: Terminated
• Conditions: Leukemia
• Intervention / Treatment: Drug: cytarabine; Drug: fludarabine phosphate; Drug: idarubicin

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Algemeen Ziekenhuis Middelheim
  • Brussels (Bruxelles), Belgium, 1090
    • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Brussels (Bruxelles), Belgium, 1020
    • Hopital Universitaire des Enfants Reine Fabiola
  • Ghent (Gent), Belgium, B-9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, B-3000
    • U.Z. Gasthuisberg
  • Liege (Luik), Belgium, 4000
    • Centre Hospitalier Regional de la Citadelle
  • Montegnee, Belgium, 4420
    • Clinique de l'Esperance
• France
  • Angers, France, 49033
    • Centre Hospitalier Regional et Universitaire d'Angers
  • Besancon, France, 25030
    • CHR de Besancon - Hopital Saint-Jacques
  • Caen, France, 14033
    • CHU de Caen
  • Grenoble, France, 38043
    • Chr De Grenoble - La Tronche
  • Lille, France, 59037
    • Centre Hospitalier Regional de Lille
  • Lyon, France, 69322
    • Hopital Debrousse
  • Montpellier, France, 34295
    • Hopital Arnaud de Villeneuve
  • Nantes, France, 44093
    • CHR Hotel Dieu
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75019
    • Hôpital Robert Debré
  • Paris, France, 75248
    • Institut Curie - Section Medicale
  • Poitiers, France, 86021
    • Hopital Jean Bernard
  • Reims, France, 51092
    • Hopital Americain
  • Strasbourg, France, 67098
    • Hopital Universitaire Hautepierre
  • Toulouse, France, 31026
    • Hopital des Enfants (Purpan Enfants)
• Portugal
  • Porto, Portugal, 4200
    • Hospital Escolar San Joao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Study Chair: Antoine Thyss, MD, Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start: December 1, 1998
• Primary Completion (Actual): April 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: December 9, 2003
• First Posted (Estimate): December 10, 2003

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 20, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: recurrent childhood acute lymphoblastic leukemia; L1 childhood acute lymphoblastic leukemia; L2 childhood acute lymphoblastic leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Fludarabine; Fludarabine phosphate; Cytarabine; Idarubicin
• Other Study ID Numbers: EORTC-58953