Spots Global Cancer Trial Database for Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma
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Trial Identification
Brief Title: Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma
Official Title: A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.
Study ID: NCT03580408
Study Description
Brief Summary: This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. : * In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12. * In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12. * In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.
Detailed Description:
Eligibility
Minimum Age: 61 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ZNA Stuivenberg, Antwerpen, , Belgium
Az Sint Jan, Bruges, , Belgium
Clinique Universitaire Saint LUC, Brussels, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Hopital Jolimont, Haine saint paul, , Belgium
Az Groeninge, Kortrijk, , Belgium
CHU de Liege, Liege, , Belgium
CHU Dinant Godinne, Yvoir, , Belgium
CHU UCL Namur, Yvoir, , Belgium
CHU d'Amiens, Amiens, , France
CH d'Avignon - Hôpital Henri Duffaut, Avignon, , France
CH Côte Basque, Bayonne, , France
CHU de Besançon - Hôpital Jean Minjoz, Besançon, , France
Institut Bergonié - Bordeaux, Bordeaux, , France
Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre, Caen, , France
CH Métropole Savoie, Chambery, , France
CHU de Clermont Ferrand, Clermont Ferrand, , France
CH Sud Francilien de Corbeil, Corbeil Essonnes, , France
APHP-Hôpital Henri Mondor, Créteil, , France
CHU de Dijon - Hôpital le Bocage, Dijon, , France
CHU de Grenoble, Grenoble, , France
CHD de Vendée, La Roche-sur-Yon, , France
CH La Rochelle, La Rochelle, , France
CH du Mans, Le Mans, , France
CH Saint Vincent de Paul, Lille, , France
CHRU de LILLE - Claude Huriez, Lille, , France
CHU de Limoges, Limoges, , France
Centre Leon Berard, Lyon Cedex 8, , France
Institut Paoli Calmette, Marseille, , France
CHRU de Metz-Thionville, Metz, , France
CHU de Montpellier - Saint Eloi, Montpellier, , France
CHU de Nantes - Hôtel Dieu, Nantes, , France
CHU de Nîmes - Caremeau, Nimes, , France
APHP - Hôpital Saint Louis, Paris Cedex 10, , France
APHP - Hopital Necker, Paris, , France
APHP - Hôpital de la Pitié Salpetrière, Paris, , France
Centre François Magendie - Hôpital du Haut Lévêque, Pessac, , France
CHU Lyon Sud, Pierre-Bénite, , France
CHU de Poitiers - Hôpital de La Milétrie, Poitiers, , France
Ch Rene Dubos, Pontoise, , France
Centre Hospitalier Annecy-Genevois - Site d'Annecy, Pringy, , France
CHU Robert Debré, Reims, , France
CHU de Rennes - Hôpital Pontchaillou, Rennes, , France
CH de Roubaix, Roubaix, , France
Centre Henri Becquerel, Rouen, , France
CH de Saint Brieuc, Saint-Brieuc, , France
CHRU de Strasbourg, Strasbourg, , France
IUCT Toulouse, Toulouse, , France
CHU Bretonneau, Tours, , France
CHU Brabois, Vandoeuvre les Nancy, , France
Institut Gustave Roussy, VILLEJUIF Cedex, , France
Contact Details
Name: Vincent RIBRAG
Affiliation: Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Role: STUDY_CHAIR
Name: Julien LAZAROVICI
Affiliation: Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Role: STUDY_CHAIR
Name: Marc ANDRE
Affiliation: CHU Dinant Godinne, UCL Namur, Yvoir - Belgium - LYSA
Role: STUDY_CHAIR
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