Spots Global Cancer Trial Database for GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma
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Trial Identification
Brief Title: GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma
Official Title: Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI
Study ID: NCT01659099
Study Description
Brief Summary: This study is designed to investigate: * the interest of a new monoclonal antibody (GA101)versus rituximab * the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ZNA Stuivenberg, Antwerpen, , Belgium
Hôpital Saint Joseph, Arlon, , Belgium
RHMS Baudour, Baudour, , Belgium
AZ St Jan Brugge Oostende AV, Brugge, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
CHU Brugmann, Bruxelles, , Belgium
Hôpital Erasme, Bruxelles, , Belgium
Clinique universitaire Saint LUC, Bruxelles, , Belgium
CHU de Charleroi, Charleroi, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Ch Jolimont, Haine Saint Paul, , Belgium
AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid, Kortrijk, , Belgium
CHR de la Citadelle, Liège, , Belgium
CHU de Liège - Clinique Saint Joseph, Liège, , Belgium
CHU de Liège -Domaine Sart Tilman, Liège, , Belgium
CHU Ambroise Paré, Mons, , Belgium
Clinique Saint Joseph -Hôpital de Warquignies, Mons, , Belgium
Clinique Sainte Elisabeth, Namur, , Belgium
Clinique Saint Pierre, Ottignies, , Belgium
Heilig Hart Ziekenhuis, Roeselare, , Belgium
Centre Hospitalier de Wallonie Picarde - CHwapi, Tournai, , Belgium
CH de la Tourelle-Peltzer, Verviers, , Belgium
Université Catholique de Louvain Mont Godinne, Yvoir, , Belgium
CH d'Abbeville, Abbeville, , France
CHU d'Amiens - Hôpital Sud, Amiens, , France
CHU d'Angers, Angers, , France
CH Victor Dupouy, Argenteuil, , France
CH d'Arras, Arras, , France
CH d'Avignon, Avignon, , France
Hôpital de Bayonne - CHU de la Côte Basque, Bayonne, , France
CH de Beauvais, Beauvais, , France
CHU de Besançon - Hôpital Jean Minjoz, Besançon, , France
CH de Blois, Blois, , France
APHP - Hôpital Avicenne, Bobigny, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
CH Dr Duchenne, Boulogne sur Mer, , France
CH Fleyriat, Bourg en Bresse, , France
CHU de Brest - Hôpital de Morvan, Brest, , France
CH Brive la Gaillarde, Brive la Gaillarde, , France
CHU de Caen, Caen, , France
Centre François Baclesse, Caen, , France
CH de Cannes, Cannes, , France
Clinique Du Parc, Castelnau Le Lez, , France
CH de Chambéry, Chambéry, , France
CHU de Châlon sur Saône, Châlon sur Saône, , France
APHP - Hôpital Antoine Béclère, Clamart, , France
Hôpital d'Instruction des Armées Percy, Clamart, , France
CHU d'Estaing, Clermont Ferrand, , France
Pôle Santé Publique, Clermont Ferrand, , France
CH de Compiègne, Compiègne, , France
CH Sud Francilien, Corbeil Essonnes, , France
APHP - Hôpital Henri Mondor, Créteil, , France
CHU de Dijon, Dijon, , France
CH de Dunkerque, Dunkerque, , France
Institut Daniel Hollard, Grenoble, , France
CHU de Grenoble, Grenoble, , France
CHD Vendée, La Roche Sur Yon, , France
CH La Rochelle, La Rochelle, , France
APHP - Hôpital Bicêtre, Le Kremlin Bicêtre, , France
CH du Mans, Le Mans, , France
Clinique Victor Hugo, Le Mans, , France
CH de Lens, Lens, , France
CH Saint Vincent de Paul, Lille, , France
CHRU Lille - Hôpital Claude Huriez, Lille, , France
CHU Dupruytren - Limoges, Limoges, , France
CH Bretagne Sud, Lorient, , France
Centre Léon Bérard, Lyon, , France
CH Mantes La Jolie, Mantes La Jolie, , France
Hôpital de la Conception, Marseille, , France
Institut Paoli Calmettes, Marseille, , France
CH de Meaux, Meaux, , France
CH Marc Jacquet, Melun, , France
Hôpital Notre Dame Bon Secours, Metz, , France
CHI de Meulan, Meulan en Yvelines, , France
CHU de Montpellier - Saint Eloi, Montpellier, , France
Centre Val d'Aurélie - Paul Lamarque, Montpellier, , France
Centre Auréen de Cancérologie, Mougins, , France
CH de Mulhouse - Hôpital Emile Muller, Mulhouse Cedex, , France
CHU de Nantes - Hôtel Dieu, Nantes, , France
Centre Catherine de Sienne, Nantes, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
CHU de Nice, Nice, , France
CHU de Nîmes, Nîmes, , France
Clinique Valdegour, Nîmes, , France
CHR d'Orléans, Orléans, , France
APHP - Hôpital Saint Louis, Paris Cedex 10, , France
APHP - Hôpital Saint Antoine, Paris Cedex 12, , France
Institut Curie, Paris, , France
APHP - Hôpital de la Pitié Salpetrière, Paris, , France
Hôpital Cochin, Paris, , France
APHP - Hôpital Necker, Paris, , France
CH Saint Jean, Perpignan, , France
CHU de Haut Lévèque, Pessac, , France
Hospices Civils de Lyon - CHU Lyon Sud, Pierre Bénite, , France
CHU de Poitiers, Poitiers, , France
CH René Dubos, Pontoise, , France
CH d'Annecy, Pringy, , France
CHU Robert Debré, Reims, , France
Institut du Cancer de Courlancy, Reims, , France
CHU de Rennes, Rennes, , France
CH de Roubaix, Roubaix, , France
Centre Henri Becquerel, Rouen, , France
Clinique Mathilde, Rouen, , France
CH Yves Le Foll - St Brieuc, Saint Brieuc, , France
Centre René Huguenin, Saint Cloud, , France
CHI de Poissy St Germain, Saint germain en laye, , France
CHU de Saint Malo, Saint Malo, , France
CH de Saint Quentin, Saint Quentin, , France
Institut de Cancérologie, St Priest en Jarez, , France
Strasbourg Oncologie Libérale, Strasbourg, , France
CHU de Strasbourg, Strasbourg, , France
Hopital Saint Husse, Toulon, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse, , France
CHU de Tours, Tours, , France
CHU de Valence, Valence, , France
CH de Valenciennes, Valenciennes, , France
CHU de Brabois, Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique, Vannes, , France
CH de Versailles, Versailles, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Olivier Casasnovas, MD
Affiliation: Lymphoma Study Association
Role: STUDY_CHAIR
Name: Steven Le Gouill, MD
Affiliation: Lymphoma Study Association
Role: STUDY_CHAIR
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