Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years

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1 Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years Status: Completed Study Phase: Phase 2 Start Date: May 2010 Completion Date: April 2014 Condition(s): Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma Full Title of Study PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA Overview This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4. The anticipated study dates (start / end) are: The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal). Patients will be recruited over 30 months and followed at least one year after the last patient has been included. The duration of the treatment period is approximately 20 weeks. Study Details Study Type: Interventional Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment Investigator Details

2 Lead Sponsor: The Lymphoma Academic Research Organisation Study Chair: Peyrade Frederic, MD Lymphoma Study Association Trial Location Details Facility: Zna Stuivenberg Antwerpen, Belgium Facility: RHMS Baudour, Belgium Facility: Az Sint Jan Av Bruges, Belgium Facility: Institut Jules Bordet Bruxelles, Belgium Facility: Universite Libre de Bruxelles - Hopital Erasme Bruxelles, Belgium Facility: Ucl de Louvain St Luc Bruxelles, Belgium Facility: Chu de Liege Bruxelles, Belgium Facility: Grand Hopital de Charleroi Charleroi, Belgium Facility: Universitair Ziekenhuis Gent Gent, Belgium Facility: Clinique Notre Dame de Grace Gosselies, Belgium Facility: Hopital Jolimont Haine Saint Paul, Belgium Facility: Ch Hutois Huy, Belgium Facility: Az Groeninge - Campus Maria'S Voorzienigheid Kortrijk, Belgium Facility: Chu Tivoli La Louvière, Belgium Facility: Chr de La Citadelle Liège, Belgium Facility: Clinique Saint Pierre Ottignies, Belgium Facility: Universite Catholique de Louvain Mont Godinne Yvoir, Belgium Facility: Ch Du Pays D'Aix Aix En Provence, France Facility: Ch Antibes Antibes, France Facility: Ch Henri Duffaut Avignon, France Facility: Hopital de Bayonne Bayonne, France Facility: Hopital Avicenne Bobigny, France

3 Facility: Polyclinique Bordeaux Nord Aquitaine Bordeaux, France Facility: Ch Du Dr Duchenne Boulogne sur Mer, France Facility: Ch de Bour En Bresse Bourg en Bresse, France Facility: Chu de Brive Brive la Gaillarde, France Facility: Chu Cote de Nacre Caen, France Facility: Centre Henri Baclesse Caen, France Facility: Ch de Cannes Cannes, France Facility: Hopital de Chalon Chalon sur Saone, France Facility: Ch Chambery Chambery, France Facility: Ch de Chartres - Hopital Louis Pasteur Chartres, France Facility: Hopital Antoine Beclere Clamart, France Facility: Hopital D'Instruction Des Armees Percy Clamart, France Facility: Hopital Pasteur Colmar, France Facility: Ch Compiege Compiegne, France Facility: Ch Sud Francilien Corbeil Essones, France Facility: Hopital Henri Mondor Creteil, France Facility: Chu Le Bocage Dijon, France Facility: Ch de Dunkerque Dunkerque, France Facility: Ch Dunkerque Dunkerque, France Facility: Ch Frejus St Raphael Frejus, France Facility: CH GERET Gueret, France Facility: Hopital Bicetre Kremlin Bicêtre, France Facility: Hopital Saint Louis La Rochelle, France Facility: Hopital Andre Mignot Le Chesnay, France Facility: Hopital St Vincent de Paul Lille, France Facility: Chu Claude Hurriez Lille, France Facility: Chu Dupuytren Limoges, France Facility: Centre Leon Berard Lyon, France Facility: Hopital Des Chanaux Macon, France

4 Facility: Chu Hopital Nord Marseille, France Facility: Institut Paoli Calmette Marseille, France Facility: Chu de Meaux Meaux, France Facility: Chu Marc Jacquet Melun, France Facility: Hopital Bon Secours Metz, France Facility: Ch de Meulan Meulan, France Facility: Crlc Val D'Aurelle - Paul Lamarque Montpellier, France Facility: Centre Azureen de Cancerologie Mougins, France Facility: Hopital Americain de Paris Neuilly sur Seine, France Facility: Centre Antoine Lacassagne Nice, France Facility: Hopital St Antoine Paris, France Facility: Hotel Dieu Paris, France Facility: Hopital St Louis Paris, France Facility: Hopital de La Pitie Salpetriere Paris, France Facility: Institut Curie Paris, France Facility: Hopital Necker Paris, France Facility: Ch Marechal Joffre Perpignan, France Facility: Chu Lyon Sud Pierre Bénite, France Facility: Chu de Poitiers - Hopital de Miletrie Poitiers, France Facility: Ch Rene Dubos Pontoise, France Facility: Ch Annecy Pringy, France Facility: Chu Robert Debre Reims, France Facility: Ch de Roubaix - Hopital Victor Provo Roubaix, France Facility: Clinique Mathilde Rouen, France Facility: Centre Henri Becquerel Rouen, France Facility: Centre Rene Hugenin Saint Cloud, France Facility: Ch de Saint Germain Saint Germain en Laye, France Facility: Hopital Font Pre Toulon, France Facility: Chu de Toulouse Toulouse, France

5 Facility: Ch de Troyes Troyes, France Facility: Hopital de Valence Valence, France Facility: Chu Brabois Vandoeuvre Les Nancy, France Facility: Institut Gustave Roussy Villejuif, France Interventions Drug: Ofatumumab solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles Information Source ID Number: LNH09-7B NCT Identifier: NCT Health Authority: France: ANSM - French Health Products Safety Agency Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/nct ClinicalTrials.gov processed this data on October 05, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.

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