EORTC protocol 06061 - AML-14A

Clofarabine in combination with a standard remissioninduction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS) : a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial)
Trial StatusRecruiting
DatesDate of activation: 21-Nov-08
Data management at EORTCFull
Phase1-2
Randomized trial
TypeHemato-malign
Targeted Sample sizeEORTC Groups: - - All Groups: 90
Number of steps1
DrugClofarabine
Cytarabine
Idarubicin
Study StaffG. Meloni (Study Coordinator) - Universita Di Roma La Sapienza - Clinica Ematologica dell'Università di Roma "La Sapienza", Roma
Dominik Selleslag (Study Coordinator) - A.Z. St. Jan, Brugge
Roel Willemze (Study Coordinator) - Leiden University Medical Centre, Leiden
Stefan Suciu (Statistician) - EORTC Headquarters, Brussels
Liv Meert (Data Manager) - EORTC Headquarters, Brussels
Safaa Ramadan (Coordinating Physician) - EORTC Headquarters, Brussels
Hilde Breyssens (Project Manager) - EORTC Headquarters, Brussels, hilde.breyssens( at )eortc.be, +32 27741004
Type of cancer
Participating GroupsEORTC Leukemia Group(Coordinating Group)
Gruppo Italiano Malattie Ematologiche dell'Adulto
Centers authorized by EORTC Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101
A.Z. St. Jan (Brugge, Belgium) - Inst. 109
C.H.U. Sart-Tilman (Liege, Belgium) - Inst. 155
Assistance Publique - Hôpitaux de Paris - Hopital Saint Antoine AP-HP (Paris, France) - Inst. 203
Universita Di Roma La Sapienza - Clinica Ematologica dell'Università di Roma "La Sapienza" (Roma, Italy) - Inst. 733
Azienda Ospedallera Universitaria - Policlinico Tor Vergata (Roma, Italy) - Inst. 3931
Jeroen Bosch Ziekenhuis ('s-Hertogenbosch, The Netherlands) - Inst. 22
Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) - Inst. 304
Protocol summaryCancer.gov (PDQ)
ClinicalTrials.gov
NCT numberNCT00838240
EudraCT2006-004912-28
Protocol documents in PDF
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Study documentation
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