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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003729
Recruitment Status : Terminated (low accrual)
First Posted : December 10, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: fludarabine phosphate Drug: idarubicin Phase 2

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  (Clinical Trial)
Actual Enrollment : 13 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children
Study Start Date : December 1998
Actual Primary Completion Date : April 2002

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003729

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

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003729     History of Changes
Other Study ID Numbers: EORTC-58953
First Posted: December 10, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors