EORTC-1301-LG

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10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients >= 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 20-Nov-2014
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 600 - All Groups: 600
Treatment	Drug Cytarabine, Daunorubicin, Decitabine, Etoposide, Idarubicin
Study Staff	Gerwin Huls (Study Coordinator) , University Medical Center Groningen, Groningen Michael Luebbert (Study Coordinator) , Universitaetsklinikum Freiburg, Freiburg Stephanie Antunes (Medical representative) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Leslie Herman (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Michal Kicinski (Statistician) , EORTC Headquarters, Brussels Davide Passariello (Clinical Operations Manager) , EORTC Headquarters, Brussels Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Jelle Stans (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer	Acute Myelogenous Leukemia
Participating groups	EORTC Leukemia Group Gruppo Italiano Malattie Ematologiche dell'Adulto
Recruiting centers	A.O.R.N. San Giuseppe Moscati (Avellino, Italy) A.O.R.N. San Giuseppe Moscati (Avellino, Italy) A.Z. St. Jan (Brugge, Belgium) APHP Sorbonne Univ- Hopital Saint Antoine (PARIS, France) AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy) AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo (Bologna, Italy) Amedeo Avogadro University of Eastern Piedmont-Ospedale Maggiore (Novara, Italy) Azienda Osp. Riunit marche Nord Ospedale San Salvatore (Pesaro, Italy) Azienda Ospedaiera San Giovanni - Addolorata (Roma, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy) Azienda Ospedaliera Univ Policlinico Paolo Giaccone (Palermo, Italy) Azienda Ospedaliera Universitaria - Policlinico Tor Vergata (Roma, Italy) Azienda Ospedaliera Universitaria Sassari (Sassari, Italy) Azienda Ospedaliera- Ospedale Riuniti Villa Sofia-Cervello (Palermo, Italy) Azienda Ospedaliero - Universitaria Policlinico di Modena (Modena, Italy) Azienda Ospedaliero Universitaria - Delle Marche (Torrette Di Ancona, Italy) Azienda Ospedaliero Universitaria Ospedali Riuniti (Foggia, Italy) Azienda Ospedaliero Universitaria Ospedali Riuniti (Foggia, Italy) Azienda USL IRCCS Di Reggio Emilia - Maria Nuova (Reggio Emilia, Italy) C.H.U. Sart-Tilman (Liege, Belgium) CHU de Caen - Hopital Cote de Nacre (CAEN CEDEX 9, France) CHU de Nantes - Hotel Dieu (NANTES CEDEX 1, France) Canisius-Wilhelmina Ziekenhuis (Nijmegen, Netherlands) Casa di Cura La Maddalena S.P.A. (Palermo, Italy) Centre Hospitalier Regional De La Citadelle (Liege, Belgium) Centre Hospitalier Regional Verviers (East Belgium) (Verviers, Belgium) Clinica Ematologica dell'Università di Roma "La Sapienza" (Roma, Italy) HELIOS Klinikum Berlin-Buch (Berlin, Germany) HagaZiekenhuis - locatie Leyweg ('S Gravenhage - Den Haag, Netherlands) Helios Klinikum Bad Saarow (Bad Saarow-Pieskow, Germany) Hospital Escolar Sao Joao (Porto, Portugal) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) IRCCS-Regina Elena National Cancer Center (Roma, Italy) Institut Jules Bordet (Anderlecht, Belgium) Klinička bolnica Merkur (Zagreb, Croatia) Martin Luther Universitaet - Universitaetsklinikum Halle (Saale) (Halle, Germany) Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands) National Specialized Hospital for Active Treatment of Hаematological Diseases (Sofia, Bulgaria) Ospedale Casa Sollievo Della Sofferenza (San Giovanni Rotondo, Italy) Ospedale Civile Pugliese-Ciaccio (Catanzaro, Italy) Ospedale San Eugenio (Roma, Italy) Ospedale Vito Fazzi Lecce (Lecce, Italy) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Reinier De Graaf Gasthuis (Delft, Netherlands) Rijnstate Hospital (Arnhem, Netherlands) Schwarzwald-Baar Klinikum Villingen Schwenninen GmbH (Villingen-Schwenningen, Germany) Univ. Rostock - Campus Schilingallee (Rostock, Germany) Univ. klinikum Augsburg (Augsburg, Germany) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Universita Degli Studi Di Bari Aldo Moro - - Policlinico (Bari, Italy) Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea (Roma, Italy) Universitaetsklinik Dusseldorf (Duesseldorf, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitaetsklinikum Giessen und Marburg - Campus Marburg (Marburg, Germany) Universitaetsklinikum Tuebingen-Uni Kliniken Berg (Tuebingen, Germany) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Brussel (Brussels, Belgium) University Hospital Centre Zagreb (Zagreb, Croatia) University Medical Center Groningen (Groningen, Netherlands) Vilnius University Hospital Santaros Klinikos (Vilnius, Lithuania) universitaetsklinikum Leipzig- Liebigstrasse-Gynaecology (Leipzig, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT02172872
NCT number	NCT02172872
EudraCT	2014-001486-27
Financial Support	Educational Grant