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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Algemeen Ziekenhuis Middelheim
      • Brussels (Bruxelles), Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Brussels (Bruxelles), Belgium, 1020
        • Hôpital 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
        • Hôpital Américain
      • Strasbourg, France, 67098
        • Hopital Universitaire Hautepierre
      • Toulouse, France, 31026
        • Hopital des Enfants (Purpan Enfants)
  • Portugal
      • Porto, Portugal, 4200
        • Hospital Escolar San Joao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Antoine Thyss, MD, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-58953

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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