NCT00003729

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 leukemia

Geographic Reach
3 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

November 1, 1999

Last Update Submit

September 20, 2012

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiaL1 childhood acute lymphoblastic leukemiaL2 childhood acute lymphoblastic leukemia

Interventions

cytarabineDRUG
fludarabine phosphateDRUG
idarubicinDRUG

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Hopital Universitaire Des Enfants Reine Fabiola

Brussels (Bruxelles), 1020, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels (Bruxelles), 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent (Gent), B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liege (Luik), 4000, Belgium

Location

Clinique de l'Esperance

Montegnée, 4420, Belgium

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

CHU de Caen

Caen, 14033, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Hopital Debrousse

Lyon, 69322, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Hopital Americain

Reims, 51092, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Hopital des Enfants (Purpan Enfants)

Toulouse, 31026, France

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cytarabinefludarabine phosphateIdarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Antoine Thyss, MD

    Centre Antoine Lacassagne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

December 10, 2003

Study Start

December 1, 1998

Primary Completion

April 1, 2002

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(15)PT(1)BE(7)