Spots Global Cancer Trial Database for Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+
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Trial Identification
Brief Title: Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+
Official Title: Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-miniCHOP + Lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association
Study ID: NCT02128061
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).
Detailed Description: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS). Primary endpoint of the study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP ((Sub-cutaneous Rituximab-miniCHOP) in patients of 80 years old or more with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS). Secondary endpoints are: * To evaluate the efficacy and the safety of R2-miniCHOP as measured by the PFS (Progression Free Survival), EFS (Event Free Survival), the DoR (duration of response), the DFS (disease free survival), response rate at the end of the treatment, the additional toxicities * To evaluate the simplified scale prognostic impact (IADL, MNA, G8, CIRS-G) * To assess the quality of life before and after treatment This study is a multicentric, phase III, open-label, randomized (1:1) trial evaluating the efficacy of R2-miniCHOP in patients aged of 80 years or more with non-previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI= 0 to 3), Ann Arbor stage II to IV with a performance status ECOG from 0 to 2. This study includes a run in phase to assess feasibility, safety and tolerance of subcutaneous rituximab injections and oral lenalidomide (10 mg D1-D14) in combination with dose-reduced intensity CHOP regimen.
Keywords
Eligibility
Minimum Age: 80 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ZNA Stuivenberg, Antwerpen, , Belgium
A. Z. Sint-Jan, Bruges, , Belgium
Hôpital Erasme, Brussel, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Université Catholique de Louvain Saint Luc, Bruxelles, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHR Citadelle, Liege, , Belgium
CHU de Liège, Liege, , Belgium
Hôpital Sainte Elisabeth, Namur, , Belgium
Clinique Saint Pierre, Ottignies, , Belgium
CHR Peltzer La Tourelle, Verviers, , Belgium
CHRU Mont Godinne, Yvoir, , Belgium
CH d'Abbeville, Abbeville, , France
CH du Pays d'Aix, Aix-en-Provence, , France
CHU d'Amiens, Amiens, , France
CHU d'Angers, Angers, , France
CH Victor Dupouy, Argenteuil, , France
CH d'Arras, Arras, , France
CH d Avignon - Hopital Henri Duffaut, Avignon, , France
CH Côte Basque, Bayonne, , France
CHU Jean Minjoz, Besancon, , France
CH de Blois, Blois, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
CH de Boulogne-sur-Mer, Boulogne-sur-mer, , France
CH de Bourg en Bresse, Bourg-en-bresse, , France
CHU Morvan, Brest, , France
CH de Brive, Brive, , France
IHBN, Caen, , France
CH de Cannes, Cannes, , France
Clinique Du Parc, Castelnau-le-lez, , France
Médipôle de Savoie, Challes-les-Eaux, , France
CHU de Châlon sur Sâone, Chalon-sur-Sâone, , France
CH Métropole Savoie, Chambery, , France
Hôpital d'Instruction des Armées Percy, Clamart, , France
CHU Estaing, Clermont-Ferrand, , France
Pôle Santé République, Clermont-Ferrand, , France
CH Sud Francilien de Corbeil, Corbeil-Essonnes, , France
APHP - Hopital Henri Mondor, Creteil, , France
CHU de Dijon - Hôpital le Bocage, Dijon, , France
CH de Dunkerque, Dunkerque, , France
CH Eure Seine, Evreux, , France
CHU de Grenoble, Grenoble, , France
Institut Daniel Hollard, Grenoble, , France
CH Départemental de Vendée, La Roche sur Yon, , France
Hôpital St Louis, La Rochelle, , France
CH de Versailles - Hopital André Mignot, Le Chesnay, , France
Hôpital Bicêtre, Le Kremlin Bicetre, , France
CH du Mans, Le Mans, , France
Clinique Victor Hugo, Le Mans, , France
CHRU Lille - Hôpital Claude Huriez, Lille, , France
Hôpital Saint Vincent de Paul, Lille, , France
CHU de Limoges, Limoges, , France
Centre Léon Bérard, Lyon, , France
CH des Chanaux, Macon, , France
Institut Paoli Calmette, Marseille, , France
Hôpital de la conception, Marseille, , France
CH de Meaux, Meaux, , France
Centre Hospitalier Annecy Genevois, Metz-Tessy, , France
Hôpital de Mercy, Metz, , France
CHU de Montpellier, Montpellier, , France
CHU de Mulhouse, Mulhouse, , France
CHU de Nantes, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
CHU de Nîmes, Nimes, , France
CHR de la Source, Orleans, , France
Hopital Saint Antoine, Paris, , France
APHP - Hôpital Saint Louis, Paris, , France
Hôpital de la Pitié Salpêtrière, Paris, , France
APHP - Hôpital Necker, Paris, , France
Clinique Francheville, Perigueux, , France
CH Périgueux, Perigueux, , France
CH de Perpigan, Perpignan, , France
CHU du Haut Leveque, Pessac, , France
Chu Lyon Sud, Pierre-Bénite, , France
CHU de Poitiers, Poitiers, , France
CH René Dubos, Pontoise, , France
CH de Cornouaille, Quimper, , France
CHU Robert Debre, Reims, , France
CHU de Rennes, Rennes, , France
CH de Roubaix, Roubaix, , France
Centre Henri Becquerel, Rouen, , France
CHU de Saint Malo, Saint Malo, , France
Groupe Hospitalier Sud Réunion, Saint Pierre, , France
CH Saint Quentin, Saint Quentin, , France
CH de Saint Brieuc, Saint-Brieuc, , France
Centre René Huguenin - Institut Curie, Saint-Cloud, , France
Strasbourg Oncologie Libérale, Strasbourg, , France
CHU de Strasbourg, Strasbourg, , France
CHI Toulon La Seyne-sur-mer, Toulon, , France
CHU Purpan - Toulouse, Toulouse, , France
CHRU Bretonneau, Tours, , France
Hôpital de Valence, Valence, , France
CHU de Brabois, Vandoeuvre les Nancy, , France
CH de Bretagne Atlantique, Vannes, , France
Contact Details
Name: Fabrice Jardin, MD,Professor
Affiliation: The Lymphoma Study Association - LYSA
Role: PRINCIPAL_INVESTIGATOR
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