Clinical Trial Details

EORTC-58951-CLG

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The value of 1) Dexamethasone vs prednisolone during induction 2) of prolonged versus conventional duration of L-Asparaginase therapy during consolidation and late intensification, in acute lymphoblastics leukemia and lymphoblastic non-Hodgkin lymphoma of childhood. A Randomised phase III study.

Study documentation Publications

Trial Status LT-FU ongoing
Dates Date of activation: 08-Dec-1998
Date Step1 close: 04-Aug-2008
Date Step2 close: 19-Sep-2008
Data management at EORTC Yes
Design Phase 3
Randomized open
Targeted Sample size EORTC Groups: 2000
Treatment Drug
Mercaptopurine, Tioguanine, L-asparaginase, Cyclophosphamide, Cytarabine, Daunorubicin, Doxorubicin, Etoposide, Methotrexate, Methylprednisolone, Prednisolone, Vincristine, Vindesine, Dexamethasone, Pegaspargase
Study Staff Jacques Otten (Study Coordinator) , Universitair Ziekenhuis Brussel, Brussels
Nathalie Crokart (Pharmacovigilance Manager) nathalie.crokart (at) eortc.be, EORTC Headquarters, Brussels
Seraphine Rossi (Data Manager) seraphine.rossi (at) eortc.be, EORTC Headquarters, Brussels
Stefan Suciu (Statistician) stefan.suciu (at) eortc.be, EORTC Headquarters, Brussels
Gaetan de Schaetzen (Project Manager) gaetan.deschaetzen (at) eortc.be, EORTC Headquarters, Brussels
Type of cancer Acute Lymphocytic Leukemia
Non Hodgkins Lymphoma
Participating groups EORTC Children's Leukemia Group
Participating centers Assistance Publique - Hopitaux de Paris - Hopital Robert Debre (Paris, France) - Inst. 408
C.H.U. De Toulouse - Hopital Des Enfants (Toulouse, France) - Inst. 2316
CHC - Clinique de l'Esperance (Saint-Nicolas (montegnee), Belgium) - Inst. 110
CHRU de Besancon - Hopital Saint-Jacques (Besancon, France) - Inst. 204
CHRU de Lille (Lille, France) - Inst. 254
CHU d'Angers (Angers, France) - Inst. 297
CHU de Caen - Hopital Cote de Nacre (Caen, France) - Inst. 273
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) - Inst. 215
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) - Inst. 215
CHU de Lyon - Institut d'Hematologie et d'Oncologie Pediatrique (Lyon, France) - Inst. 239
CHU de Nantes - Hopital Mere et Enfant (Nantes, France) - Inst. 9041
CHU de Nantes - Hopital Mere et Enfant (Nantes, France) - Inst. 9041
CHU de Nice - Hopital De L'Archet (Nice, France) - Inst. 2292
CHU de Reims - American Memorial Hospital (Reims, France) - Inst. 265
Centre Antoine Lacassagne (Nice, France) - Inst. 218
Centre Hospitalier Regional De La Citadelle (Liege, Belgium) - Inst. 145
Hopital Arnaud De Villeneuve (Montpellier, France) - Inst. 244
Hopital Jean Bernard (Poitiers, France) - Inst. 296
Hopital Universitaire Des Enfants Reine Fabiola (Brussels, Belgium) - Inst. 159
Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg, France) - Inst. 240
Hospital Escolar Sao Joao (Porto, Portugal) - Inst. 807
Hospital Escolar Sao Joao (Porto, Portugal) - Inst. 807
Instituto Portugues De Oncologia - Centro Do Porto (Porto, Portugal) - Inst. 804
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) - Inst. 147
Universitair Ziekenhuis Brussel (Brussels, Belgium) - Inst. 128
Universitair Ziekenhuis Gent (Gent, Belgium) - Inst. 104
ZNA Middelheim (Antwerpen, Belgium) - Inst. 114
Protocol summary http://clinicaltrials.gov/ct/show/NCT00003728
NCT number NCT00003728