Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Registration Number
- NCT02416388
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R4-HDAC (without DEX) HD Cytarabine High dose cytarabine alone R4-VEN-IDAC ID cytarabine Intermediate dose cytarabine and venetoclax R2-IDAC ID cytarabine Intermediate dose cytarabine R4-VOS-IDAC ID cytarabine Intermediate dose cytarabine and vosaroxin R1-IDA Idarubicin Idarubicin R3-MAC-MPA Cyclosporine Cyclosporine and mycophenolic acid R4-DEX-HDAC HD Cytarabine High dose cytarabine and dexamethasone R2-HDAC HD Cytarabine High dose cytarabine R3-MAC-MPA Mycophenolic acid (MPA) Cyclosporine and mycophenolic acid R3-RIC-MPA Mycophenolic acid (MPA) Cyclosporine and mycophenolic acid R3-MAC-MTX Methotrexate Methotrexate and mycophenolic acid R3-MAC-MTX Mycophenolic acid (MPA) Methotrexate and mycophenolic acid R3-RIC-CICLO Cyclosporine Cyclosporine R4-VOS-IDAC vosaroxin Intermediate dose cytarabine and vosaroxin R4-DEX-HDAC Dexamethasone High dose cytarabine and dexamethasone R4-IDAC (without VOS) ID cytarabine Intermediate dose cytarabine alone R4-IDAC (without VEN) ID cytarabine Intermediate dose cytarabine alone R3-RIC-MPA Cyclosporine Cyclosporine and mycophenolic acid R1-DAUNO Daunorubicin Daunorubicin R4-VEN-IDAC Venetoclax Intermediate dose cytarabine and venetoclax
- Primary Outcome Measures
Name Time Method Cumulative incidence (CI) of acute Graft versus Host Disease (GvHD) of grade II to IV 100 days For randomization R3 : GvHD prophylaxis study
Disease free survival 18 months For randomizations R4
Overall survival 3 years For randomizations R1 (idarubicine vs daunorubicine) and R2 (HDAC vs IDAC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
CH Amiens Hôpital Sud
🇫🇷Amiens, France
CHU Angers
🇫🇷Angers, France
CH Victor Dupouy
🇫🇷Argenteuil, France
Hôpital Jean Minjoz
🇫🇷Besancon, France
Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital du Dr Duchenne
🇫🇷Boulogne sur Mer, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
CH Beziers
🇫🇷Beziers, France
CH Bordeaux
🇫🇷Bordeaux, France
Hôpital Morvan
🇫🇷Brest, France
CH Caen
🇫🇷Caen, France
Clinique du parc
🇫🇷Castelnau Le lez, France
Centre Hospitalier René Dubos
🇫🇷Cergy Pontoise, France
HIA Percy
🇫🇷Clamart, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil Essonnes, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Hôpital Henri Mondor
🇫🇷Créteil, France
CHU de Dijon
🇫🇷Dijon, France
CH Dunkerque
🇫🇷Dunkerque, France
Hôpital Michallon
🇫🇷Grenoble, France
CH Versailles
🇫🇷Le Chesnay, France
CH Lens
🇫🇷Lens, France
Hôpital St Vincent de Paul
🇫🇷Lille, France
CHU de Limoges
🇫🇷Limoges, France
Centre Leon Berard (CLB)
🇫🇷Lyon, France
Marseille La Conception
🇫🇷Marseille, France
Institut Paoli Calmettes
🇫🇷Marseille, France
CH Meaux
🇫🇷Meaux, France
CHR Metz Thionville_Hôpital de Mercy
🇫🇷Metz, France
Hôpital Saint Eloi
🇫🇷Montpellier, France
CH Mulhouse
🇫🇷Mulhouse, France
CH Hôtel Dieu
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
CHRU de Nîmes
🇫🇷Nîmes, France
CHU Nice
🇫🇷Nice, France
Hôpital La Pitié Salpêtrière
🇫🇷Paris, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Necker Enfants Malades
🇫🇷Paris, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital St Louis
🇫🇷Paris, France
CHU de Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Saint Jean
🇫🇷Perpignan, France
CH Pontchaillou
🇫🇷Rennes, France
Hopital Victor Provo
🇫🇷Roubaix, France
Hôpital René Huguenin
🇫🇷St Cloud, France
IUCT Toulouse
🇫🇷Toulouse, France
Hôpital Hautepierre
🇫🇷Strasbourg, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷St Priest en Jarez, France
Institut de Cancérologie Gustave Roussy
🇫🇷Villejuif, France
Hôpitaux de Brabois_CHU Nancy
🇫🇷Vandoeuvre-les-Nancy, France
CHU Bretonneau
🇫🇷Tours, France
CH Valenciennes
🇫🇷Valenciennes, France
CHRU de Lille, Hôpital Huriez
🇫🇷Lille, France
Hôpital Robert Debré
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
CH Lyon Sud
🇫🇷Lyon, France