EORTC protocol 58951

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.
Trial StatusClosed for recruitment
DatesDate of activation: 08-Dec-98
Date Step1 close: 04-Aug-08
Data management at EORTCFull
Phase3
Randomized trialYes
TypeAdvanced
Targeted Sample size2000
Number of steps3
DrugMercaptopurine
Tioguanine
L-asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Methotrexate
Methylprednisolone
Prednisolone
Vincristine
Vindesine
Dexamethasone
Pegaspargase
Study StaffJacques Otten (Study Coordinator) - Universitair Ziekenhuis Brussel, Brussels
Stefan Suciu (Statistician) - EORTC Headquarters, Brussels
Lies Meirlaen (Data Manager) - EORTC Headquarters, Brussels
Séraphine Rossi (Data Manager) - EORTC Headquarters, Brussels
Gaetan de Schaetzen (Project Manager) - EORTC Headquarters, Brussels, gaetan.deschaetzen( at )eortc.be, +32 27741618
Type of cancerAcute Lymphocytic Leukemia
Non Hodgkins Lymphoma
Participating GroupsEORTC Children's Leukemia Group(Coordinating Group)
Protocol summaryCancer.gov (PDQ)
ClinicalTrials.gov
NCT numberNCT00003728
EudraCT
Protocol documents in PDF
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Study documentation
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