606
Participants
Start Date
November 28, 2014
Primary Completion Date
March 7, 2022
Study Completion Date
December 31, 2023
standard combination chemotherapy
"1. Cycle 1~ 1. daunorubicin (60 mg/m²) infusion (15-30 min) for 3 days~ 2. cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days.~2. Cycle 2~ 1. daunorubicin (45 mg/m²) infusion (15-30 min) for 3 days~ 2. cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days.~3. Cycle 3 (mini-ICE)~ 1. idarubicin (8 mg/m²) infusion (15-30 min) for 3 days~ 2. cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days~ 3. etoposide (100 mg/m²) infusion (1 hr) for 3 days~4. Cycle 4 (mini-ICE) (optional)~ 1. idarubicin (8 mg/m²) infusion (15-30 min) for 3 days~ 2. cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days~ 3. etoposide (100 mg/m²) infusion (1 hr) for 3 days"
decitabine
"1. Cycle 1: decitabine (20 mg/m²) infusion (1 hr) for 10 days~2. Cycle 2~ 1. if bone marrow (BM) blasts \< 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days~ 2. if BM blasts \>= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days~3. Cycle 3~ 1. if BM blasts \< 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days~ 2. if BM blasts \>= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days~4. Cycle 4-6: decitabine (20 mg/m²) infusion (1 hr) for 5 days~5. Continuation therapy from Cycle 7 and until 'progression or toxicity': decitabine (20 mg/m²) infusion (1 hr) for 5 days or 3 days~Note: All patients considered eligible for transplant should be consolidated with alloHCT once donor is available."
Institut Jules Bordet, Brussels
UZ Brussel, Jette
National Specialized Hospital for Active Treatment of Haematological Diseases, Sofia
UZ Antwerpen, Edegem
C.H.U. Sart-Tilman, Liège
CHR De La Citadelle, Liège
CHR Verviers, Verviers
A.Z. St. Jan, Bruges
Clinical Hospital Merkur, Zagreb
University Hospital Rebro, Zagreb
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette, Torino
Helios Kliniken - Helios Klinikum Berlin-Buch, Berlin
CHU de Caen - Hôpital Côte de Nacre, Caen
Universitaet Rostock - Medizinische Fakultaet, Rostock
Amedeo Avogadro University of Eastern Piedmont-Ospedale Maggiore della Carita, Novara
"Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine", Udine
Klinikum Der Phillips - Universität Marburg, Marburg
Universita di Bologna, Bologna
Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena
Arcispedale Di S. Maria Nuova, Reggio Emilia
CHU de Nantes - Hôtel Dieu, Nantes
Universitätsklinikum Essen, Essen
AUSL Romagna - Ospedale Infermi di Rimini, Rimini
AUSL Romagna - Ospedale Santa Maria dell Croci, Ravenna
Universitätsklinikum Aachen AÖR - Medizinische Fakultät der RWTH, Aachen
Azienda Ospedaliero Universitaria - Ospedali Riuniti, Ancona
Ospedale San Salvatore, Pesaro
Universita Degli Studi Di Bari - Policlinico, Bari
Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo
Ospedali Riuniti Foggia, Foggia
Universitaetsklinikum Tuebingen-Uni Kliniken Berg, Tübingen
Assistance Publique - Hôpitaux de Paris - Hôpital Saint Antoine, Paris
Universitätsklinikum Freiburg, Freiburg im Breisgau
Klinikum Augsburg, Augsburg
Ospedale Regionale A. Pugliese, Catanzaro
La Maddalena S.P.A., Palermo
Universitaetklinikum Halle - Martin Luther Universitaet - Universitaetsklinikum Halle (Saale), Halle
H. San Giovanni - Addolorata, Roma
Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea, Roma
Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Rome
Instituto Regina Elena / Instituti Fisioterapici Ospitalieri, Rome
Ospedale San Eugenio, Rome
Clinica Ematologica dell'Universita di Roma La Sapienza, Rome
Vilnius University Hospital Santariskiu Clinics, Vilnius
Rijnstate Hospital, Arnhem
Reinier De Graaf Gasthuis, Delft
Unversity Medical Center Groningen, Groningen
Medisch Centrum Leeuwarden-Zuid, Leeuwarden
Academisch Ziekenhuis Maastricht, Maastricht
Radboud University Medical Center Nijmegen, Nijmegen
Canisius-Wilhelmina Ziekenhuis, Nijmegen
HagaZiekenhuis - locatie Leyweg, The Hague
Hospital Escolar Soa Joao, Porto
Collaborators (1)
Janssen Pharmaceuticals
INDUSTRY
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK