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Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults. A prospective randomized trial.

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 19-Dec-2011
Date Step1 close: 10-Nov-2016
Data management at EORTC No
Design Phase 2-3
Randomized open label
Targeted Sample size EORTC Groups: 15 - All Groups: 340
Treatment Drug
Mercaptopurine, Tioguanine, Clofarabine, Cytarabine, Daunorubicin, Doxorubicin, Etoposide, Leucovorin, Methotrexate, Prednisolone, Prednisone, Vinblastine, Vincristine, Vindesine, Dexamethasone
Study Staff Jean-Pierre Marie (Study Coordinator) , Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine, Paris
Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at), EORTC Headquarters, Brussels
Liv Meert (Data Manager) liv.meert (at), EORTC Headquarters, Brussels
Stefan Suciu (Statistician) stefan.suciu (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at), EORTC Headquarters, Brussels
Type of cancer Acute Lymphocytic Leukemia
Participating groups EORTC Leukemia Group
Hemato-Oncologie Volwassenen Nederland
Recruiting centers Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine (Paris, France)
Protocol summary
NCT number
EudraCT 2008-005798-36