Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Phase II/III Randomized Study to Improve Overall Survival 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 Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial
Study ID: NCT02416388
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CH Amiens Hôpital Sud, Amiens, , France
CHU Angers, Angers, , France
CH Victor Dupouy, Argenteuil, , France
Centre Hospitalier de la Côte Basque, Bayonne, , France
Hôpital Jean Minjoz, Besancon, , France
CH Beziers, Beziers, , France
Hôpital Avicenne, Bobigny, , France
CH Bordeaux, Bordeaux, , France
Hôpital du Dr Duchenne, Boulogne sur Mer, , 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
CHU Estaing, Clermont-Ferrand, , France
Centre Hospitalier Sud Francilien, Corbeil Essonnes, , 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
CHRU de Lille, Hôpital Huriez, Lille, , France
Hôpital St Vincent de Paul, Lille, , France
CHU de Limoges, Limoges, , France
Centre Leon Berard (CLB), Lyon, , France
CH Lyon Sud, Lyon, , 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
CHU Nice, Nice, , France
CHRU de Nîmes, Nîmes, , France
Hôpital Cochin, Paris, , France
Hôpital La Pitié Salpêtrière, Paris, , France
Hôpital Necker Enfants Malades, Paris, , France
Hôpital Saint Antoine, Paris, , France
Hôpital St Louis, Paris, , France
Centre Hospitalier Saint Jean, Perpignan, , France
CHU de Poitiers, Poitiers, , France
Hôpital Robert Debré, Reims, , France
CH Pontchaillou, Rennes, , France
Hopital Victor Provo, Roubaix, , France
Centre Henri Becquerel, Rouen, , France
Hôpital René Huguenin, St Cloud, , France
Institut de Cancérologie Lucien Neuwirth, St Priest en Jarez, , France
Hôpital Hautepierre, Strasbourg, , France
IUCT Toulouse, Toulouse, , France
CHU Bretonneau, Tours, , France
CH Valenciennes, Valenciennes, , France
Hôpitaux de Brabois_CHU Nancy, Vandoeuvre-les-Nancy, , France
Institut de Cancérologie Gustave Roussy, Villejuif, , France
Contact Details
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