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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 CEDEX 12
Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Liv Meert (Data Manager) , EORTC Headquarters, Brussels
Stefan Suciu (Statistician) , EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) , 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 CEDEX 12, France)
Protocol summary
NCT number
EudraCT 2008-005798-36
Financial Support EORTC Group