3,100
Participants
Start Date
January 31, 2015
Primary Completion Date
July 31, 2025
Study Completion Date
January 31, 2032
Idarubicin
"Induction chemotherapy :~Idarubicin 9mg/m² /day, from D1 to D5 (IV, 30min)~\+ cytarabine 200mg/m²/day from D1 to D7 (IV 24 h)~Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L)."
Daunorubicin
"Induction chemotherapy :~Daunorubicin 90mg/m²/day, from D1 to D3 (IV, 30min)~\+ cytarabine 200mg/m² /day from D1 to D7 (IV 24 h)~Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L)."
HD Cytarabine
"Consolidation chemotherapy course (s) :~-High dose cytarabine: 3g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group"
Cyclosporine
"GvHD prophylaxis post allogeneic SCT :~-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100"
Methotrexate
"GvHD prophylaxis post allogeneic SCT :~-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11"
Mycophenolic acid (MPA)
"GvHD prophylaxis post allogeneic SCT :~* 720 mg BID from D0 to D+28 for HLA-identical siblings~* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors"
vosaroxin
"Consolidation chemotherapy course (s) :~-70 mg/m² on D1 and D4"
ID cytarabine
"Consolidation chemotherapy course (s) :~-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)~Up to 3 consolidation courses, depending on the patient AML risk group"
Dexamethasone
"Consolidation chemotherapy course (s) :~-10 mg/12h on D1, D3 and D5"
Venetoclax
"Consolidation chemotherapy course (s) :~Once RP2D has been determined from the results of the dose selection phase (phase 1), the optimal dose level retained for randomized phase 2 will be one of the following:~* 100 mg/d on D1 to D8 (selection phase dose level 1)~* or 200 mg/d on D1 to D8 (selection phase dose level 2)~* or 400 mg/d on D1 to D8 (selection phase dose level 3)~* or 400 mg/d on D1 to D14 (selection phase dose level 4)"
RECRUITING
Marseille La Conception, Marseille
WITHDRAWN
Clinique du parc, Castelnau-le-Lez
RECRUITING
CHU Angers, Angers
RECRUITING
CH Amiens Hôpital Sud, Amiens
RECRUITING
CH Victor Dupouy, Argenteuil
RECRUITING
Centre Hospitalier de la Côte Basque, Bayonne
RECRUITING
Hôpital Jean Minjoz, Besançon
RECRUITING
CH Beziers, Béziers
RECRUITING
Hôpital Avicenne, Bobigny
RECRUITING
CH Bordeaux, Bordeaux
RECRUITING
Hôpital du Dr Duchenne, Boulogne-sur-Mer
RECRUITING
Hôpital Morvan, Brest
RECRUITING
CH Caen, Caen
RECRUITING
Centre Hospitalier René Dubos, Cergy-Pontoise
RECRUITING
HIA Percy, Clamart
RECRUITING
CHU Estaing, Clermont-Ferrand
RECRUITING
Centre Hospitalier Sud Francilien, Corbeil-Essonnes
RECRUITING
Hôpital Henri Mondor, Créteil
RECRUITING
CHU de Dijon, Dijon
RECRUITING
CH Dunkerque, Dunkirk
RECRUITING
Hôpital Michallon, Grenoble
RECRUITING
CH Versailles, Le Chesnay
RECRUITING
CH Lens, Lens
RECRUITING
CHRU de Lille, Hôpital Huriez, Lille
RECRUITING
Hôpital St Vincent de Paul, Lille
RECRUITING
CHU de Limoges, Limoges
RECRUITING
Centre Leon Berard (CLB), Lyon
RECRUITING
CH Lyon Sud, Lyon
RECRUITING
Institut Paoli Calmettes, Marseille
RECRUITING
CH Meaux, Meaux
RECRUITING
CHR Metz Thionville_Hôpital de Mercy, Metz
RECRUITING
Hôpital Saint Eloi, Montpellier
RECRUITING
CH Mulhouse, Mulhouse
RECRUITING
CH Hôtel Dieu, Nantes
RECRUITING
Centre Antoine Lacassagne, Nice
RECRUITING
CHU Nice, Nice
RECRUITING
CHRU de Nîmes, Nîmes
RECRUITING
Hôpital Cochin, Paris
RECRUITING
Hôpital La Pitié Salpêtrière, Paris
RECRUITING
Hôpital Necker Enfants Malades, Paris
RECRUITING
Hôpital Saint Antoine, Paris
RECRUITING
Hôpital St Louis, Paris
RECRUITING
Centre Hospitalier Saint Jean, Perpignan
RECRUITING
CHU de Poitiers, Poitiers
RECRUITING
Hôpital Robert Debré, Reims
RECRUITING
CH Pontchaillou, Rennes
RECRUITING
Hopital Victor Provo, Roubaix
RECRUITING
Centre Henri Becquerel, Rouen
RECRUITING
Hôpital René Huguenin, Saint-Cloud
RECRUITING
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez
RECRUITING
Hôpital Hautepierre, Strasbourg
RECRUITING
IUCT Toulouse, Toulouse
RECRUITING
CHU Bretonneau, Tours
RECRUITING
CH Valenciennes, Valenciennes
RECRUITING
Hôpitaux de Brabois_CHU Nancy, Vandœuvre-lès-Nancy
RECRUITING
Institut de Cancérologie Gustave Roussy, Villejuif
University Hospital, Angers
OTHER_GOV