170
Participants
Start Date
October 14, 2014
Primary Completion Date
July 5, 2021
Study Completion Date
August 16, 2021
Decitabine
"Decitabine (DAC) will be administered at 20 mg/m2 intravenously daily for 5 days every 28 days. Hydroxyurea may be added during the first 3 cycles if WBC counts \> 30 G/L, and mandatory if WBC \> 50 G/L. The daily dose will be adapted to maintain WBC below 15 to 20 G/L.~Treatment will be continued until an event is reached. Events and thus study exit will be acknowledged only after agreement between the investigator and a Trial Committee."
HYDROXYUREA
"Hydroxyurea (HY) 1g/d once daily, with dose adjustments (up to 4g/d) to maintain a WBC count between 5 and 10 G/L. Allopurinol, 300mg/d started at the time of inclusion will be administered to all patients.~Treatment will be continued until an event is reached. Events and thus study exit will be acknowledged only after agreement between the investigator and a Trial Committee."
Institut Paoli-Calmette, Marseille
CHU Côte de Nacre, Caen
CH Valence, Valence
CHU de Brest - Hôpital Morvan, Brest
CHU de Nîmes, Nîmes
IUCT Oncopole - Département d'hématologie, Toulouse
Iuct Oncopole, Toulouse
CHU de Haut-Lévèque, Pessac
Clinique Beausoleil, Montpellier
Hôpital Saint Eloi, Montpellier
CHU Pontchaillou, Rennes
Hôpital privé Sévigné, Cesson-Sévigné
CHU Albert Michallon, Grenoble
Hopital de l'Hotel Dieu, Nantes
CHR d'Orléans, Orléans
CHU de Reims, Reims
CHU Brabois, Vandœuvre-lès-Nancy
Hôpital Saint Vincent de Paul, Lille
CH de Compiègne, Compiègne
CHU Estaing, Clermont-Ferrand
Centre Hospitalier de La Cote Basque, Bayonne
Centre Hospitalier Joffre, Perpignan
Hôpital Hautepierre, Strasbourg
Centre Hospitalier Lyon Sud, Lyon
CH Le Mans, Le Mans
Clinique Victor Hugo, Le Mans
CH Annecy Genevois, Pringy
Hopital St Louis T4, Paris
Centre Henri Bequerel, Rouen
Centre Hospitalier de Meaux, Meaux
Chu Amiens, Amiens
Ch Avignon, Avignon
CHU Poitiers, Poitiers
CHRU de Limoges, Limoges
Hôpital Nord Franche-Comté, Belfort
Centre Hospitalier Sud-Francilien, Corbeil-Essonnes
Hôpital Avicenne, Bobigny
Centre Henri Mondor, Créteil
Institut gustave Roussy, Villejuif
CH René Dubos, Pontoise
CH Victor Dupouy, Argenteuil
CHU La Réunion - Site nord, Saint-Denis
CHU La Réunion-Site Sud, Saint-Pierre
CHU d'Angers, Angers
Hopital Archet I, Nice
Janssen-Cilag Ltd.
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER