Study

EORTC-1301-LG

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 Back to result

Trial Status

LT-FU ongoing

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
Davide Passariello (Project Manager), EORTC Headquarters, Brussels
Stephanie Antunes (Medical representative), EORTC Headquarters, Brussels
Michal Kicinski (Statistician), EORTC Headquarters, Brussels
Davide Passariello (Clinical Operations Manager), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
Leslie Herman (Regulatory Affairs Manager), EORTC Headquarters, Brussels
Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
Lucy Sepulveda (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Administrator), 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.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 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 Renato Dulbecco-Ospedale Civile Pugliese-Ciaccio (Catanzaro, Italy)
Azienda Sanitaria Territoriale Di Pesaro E Urbino Ospedale San Salvatore(A O. Riuniti marche Nord) (Pesaro, 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)
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)
HagaZiekenhuis - locatie Leyweg ('S Gravenhage - Den Haag, Netherlands)
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 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 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)

Centers to be activated

AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy)
Azienda Ospedaliera Universitaria Pisana (Pisa, Italy)
Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario "Santa Maria della Misericordia" ) (Udine, Italy)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Roma, Italy)
Fondazione di Ricerca e Cura Giovanni Paolo II - UNiversità Cattolica del Sacro Cuore (Campobasso, Italy)
Ospedale S. Gennaro (Napoli, Italy)
San Camillo Forlanini Hospitals (Roma, Italy)

Protocol summary

http://clinicaltrials.gov/study/NCT02172872

NCT number

NCT02172872

EudraCT

2014-001486-27