NCT00003650

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P25-P50 for phase_3 lymphoma

Timeline
Completed

Started Feb 1997

Longer than P75 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

11.8 years

First QC Date

November 1, 1999

Last Update Submit

February 19, 2021

Conditions

Lymphoma

Keywords

stage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphoma

Interventions

asparaginaseDRUG
cyclophosphamideDRUG
cytarabineDRUG
daunorubicin hydrochlorideDRUG
dexamethasoneDRUG
etoposideDRUG
mercaptopurineDRUG
methotrexateDRUG
methylprednisoloneDRUG
mitoxantrone hydrochlorideDRUG
prednisoneDRUG
vincristine sulfateDRUG
radiation therapyRADIATION

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed T cell or pre-B cell non-Hodgkin's lymphoma * Lymphoblastic or peripheral T cell * Stage I, II, III, or IV * No anaplastic lymphoma, large cell lymphoma, or small noncleaved cell lymphoma PATIENT CHARACTERISTICS: Age: * 18 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior malignancy * No chronic medical or psychological condition * No congenital immunodeficiency * HIV and HTLV negative * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior corticosteroids allowed Radiotherapy: * Not specified Surgery: * No prior organ transplant

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

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69373, France

Location

Related Publications (1)

  • Ducassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7.

    PMID: 21210776BACKGROUND

MeSH Terms

Conditions

Lymphoma

Interventions

AsparaginaseCyclophosphamideCytarabineDaunorubicinDexamethasoneEtoposideMercaptopurineMethotrexateMethylprednisoloneMitoxantronePrednisoneVincristineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesSulfhydryl CompoundsSulfur CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAminopterinPterinsPteridinesPrednisoloneAnthraquinonesAnthronesAnthracenesQuinonesPregnadienediolsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizinesTherapeutics

Study Officials

  • Christophe Bergeron

    Centre Leon Berard

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

February 1, 1997

Primary Completion

December 1, 2008

Study Completion

November 1, 2013

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

FR(1)