The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Official Title: Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
Study ID: NCT01122472
Brief Summary: This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
Detailed Description: Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21 regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local preferences. Patients can be registered to participate in the study at two time points: * At time of initial diagnosis and study enrolment (signature of informed consent) before the first cycle of treatment with R-CHOP. * At randomization (signature of informed consent) after treatment in first line with R-CHOP and have reached at least PR or CR. Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for Malignant Lymphoma(2007). Stratification: Before randomization, the patients will be stratified according to the country and the response to R-CHOP (PR vs CR). Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with lenalidomide or placebo.
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Bendigo Hospital, Bendigo, , Australia
Concord Repatriation General Hospital, Concord, , Australia
Flinders Medical Centre - Repatriation General Hospital, Daw Park, , Australia
St Vincent's Hospital, Melbourne, Fitzroy, , Australia
Frankston Hospital Monash Medical Centre, Frankston, , Australia
Fremantle Hospital, Fremantle, , Australia
Canberra Hospital, Garran, , Australia
Austin Hospital, Heidelberg, , Australia
Royal Hobart Hospital, Hobart, , Australia
Mater Misericordiae Hospital - Calvary Mater NewCastle, Hunter, , Australia
St George Hospital, Kogarah, , Australia
Sir Charles Gardiner Hospital, Nedlands, , Australia
Gold Coast Hospital, Southport, , Australia
Albury Base Hospital/Murray Valley Private Hospital, Wodonga, , Australia
Queen Elizabeth Hospital, Woodville, , Australia
LKH Feldkirch, Feldkirch, , Austria
Medizinische Universität Innsbruck für Innere Medizin, Innsbruck, , Austria
LKH Leoben-Eisenerz Department für Hämato-Onkologie, Leoben, , Austria
Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner, Linz, , Austria
Krankenhaus der Elisabethinen Linz GmbH, Linz, , Austria
AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un, Linz, , Austria
Universitätklinik der PMU Salzburg - Für Innere Medizin III, Salzburg, , Austria
Landeskrankenhaus Steyr - Innere Medizin II, Steyr, , Austria
Uniersitätsklinik f. Innere Medizin I, Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
ZNA Middelheim, Antwerpen, , Belgium
ZNA Stuivenberg, Antwerpen, , Belgium
Hopital Saint Joseph, Arlon, , Belgium
A.Z. Sint Jan AV, Bruges, , Belgium
CHU Brugmann, Bruxelles, , Belgium
Institut Jules BORDET, Bruxelles, , Belgium
Universite Catholique de Louvain Saint Luc, Bruxelles, , Belgium
CH Notre Dame, Charleroi, , Belgium
CHU Charleroi-Vesale, Charleroi, , Belgium
Centre de Sante des Fagnes, Chimay, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Clinique Notre Dame de Grace, Gosselies, , Belgium
Hopital Jolimont, Haine saint paul, , Belgium
CH Hutois, HUY, , Belgium
AZ VUB, Jette, , Belgium
AZ Groeninge - Campus Maria s Voorzienigheid, Kortrijk, , Belgium
CHR de la Citadelle, Liege, , Belgium
CHU de Liege, Liege, , Belgium
CHU Ambroise Pare, Mons, , Belgium
Clinique Saint Joseph, Mons, , Belgium
Hopital Sainte Elisabeth, Namur, , Belgium
Clinique Saint Pierre, Ottignies, , Belgium
Heilig Hart Ziekenhuis, Roeselare, , Belgium
CH de la Tourelle-Peltzer, Verviers, , Belgium
A.Z. Sint-Augustinus, Wilrijk, , Belgium
Universite Catholique de Louvain Mont Godinne, Yvoir, , Belgium
CHR de la Région d'Annecy, Annecy Cedex, , France
CH Antibes-Juan les Pins, Antibes, , France
CH d'Arras, Arras Cedex, , France
Hopital Henri DUFFAUT, Avignon, , France
Hopital de BAYONNE, Bayonne, , France
CHG Mail Pierre Charlot, Blois, , France
Hôpital d'Avicenne, Bobigny, , France
Hopital Jean VERDIER, BONDY Cedex, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Hopital DUCHENNE, Boulogne sur Mer, , France
CH de Bourg-en-Bresse, Bourg-en-Bresse, , France
Centre Hospitalier de Brive, Brive-La-Gaillarde, , France
Centre François Baclesse, CAEN Cedex 05, , France
CHU Clémenceau- Côte de Nacre, Caen Cedex, , France
CH de Cannes, Cannes, , France
Hôpital de Châlon, Chalon sur Saone, , France
Centre Hospitalier, Chambery, , France
CH Chartres, Chartres Cedex, , France
Hopital Antoine Béclère, Clamart, , France
Hôpital des instructions des Armées PERCY, Clamart, , France
Hopital Louis Pasteur, Colmar Cedex, , France
CH de Compiègne, Compiegne Cedex, , France
Hopital Sud Francilien, Corbeil-Essonnes, , France
CH Henri Mondor, Créteil, , France
CHU le Bocage, Dijon, , France
CH de Dunkerque, Dunkerque, , France
CHI Evreux, Evreux, , France
CHI Fréjus Saint Raphaêl, Frejus, , France
Institut Daniel Hollard, Grenoble, , France
Centre Hospitalier de Guéret, Gueret, , France
CHG La Rochelle, La Rochelle Cedex 01, , France
Hopital André Mignot, Le Chesnay, , France
Hopital Bicêtre, Le Kremlin-Bicêtre, , France
Clinique Victor Hugo - Centre Jean Bernard, LE Mans, , France
CHU de Lens, Lens, , France
CHRU de Lille, Lille Cedex, , France
Hôpital Saint Vincent de Paul, Lille, , France
Hopital DUPUYTREN, LIMOGES Cedex, , France
Centre Léon Bérard, LYON Cedex 08, , France
Clinique de la Sauvegarde, Lyon, , France
CH les CHANAUX, Macon Cedex, , France
Institut Paoli Calmettes, Marseille Cedex, , France
Hopital Nord, Marseille, , France
CHG Meaux, Meaux, , France
CH Marc JACQUET, MELUN Cedex, , France
Hopital Notre Dame de Bon Secours, Metz Cedex, , France
CRLC Val d'Aurelle, Montpellier Cedex, , France
Centre Azuréen de Cancérologie, Mougins, , France
Hopital Emile Muller- CHU Mulhouse, MULHOUSE Cedex, , France
Hôpital Américain de Paris, Neuilly sur seine, , France
Centre Antoine Lacassagne, Nice, , France
CHU de Nice, Nice, , France
Hôtel Dieu, Paris Cedex 04, , France
Institut Curie, Paris Cedex 05, , France
Hopital de la Pitié Salpetrière, Paris Cedex 13, , France
Hopital Saint Antoine, Paris, , France
Hopital St-Louis, Paris, , France
Hopital NECKER, Paris, , France
CH de Perpignan, Perpignan, , France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France
CH René DUBOS, Pontoise, , France
Hopital Robert DEBRE, REIMS Cedex, , France
Centre Henri BECQUEREL, Rouen, , France
Clinique Mathilde, Rouen, , France
Centre René Huguenin, Saint Cloud Cedex, , France
CHG Saint Germain, St Germain en Laye, , France
CHI Toulon La Seyne-sur-mer, Toulon, , France
CHU Purpan Pav. Dieulafoy, Toulouse Cedex 9, , France
Hopital de Troyes, Troyes Cedex, , France
CH Valence, Valence Cedex 9, , France
CH de Valenciennes, Valenciennes, , France
CHU Nancy Brabois, Vandœuvre-lès-Nancy, , France
Institut Gustave ROUSSY, VILLEJUIF Cedex, , France
Haemek Medical Center, Afula, , Israel
Barzilai Medical Center, Ashkelon, , Israel
Soroka, Beer sheva, , Israel
Bnai-Zion medical center, Haifa, , Israel
Meir Medical Center, Kfar saba, , Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikwah, , Israel
Kaplan Medical Center, Rehovot, , Israel
SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, , Poland
Klinika Hematologii Collegium Medicum UJ, Krakow, , Poland
Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny, Lodz, , Poland
Medical University of Warsaw, Warsaw, , Poland
Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii, Warszawa, , Poland
Hospitais da Universidade de Coimbra, Coimbra, , Portugal
Instituto Português de Oncologia de Lisboa de Francisco Gentil, Lisboa, , Portugal
Hospital de Santa Maria, Lisboa, , Portugal
IPO - Francisco Gentil - Porto, Porto, , Portugal
Complejo Hospitalario Universitario de A Coruna, A coruna, , Spain
Hospital Universitario Fundacion Alcorcon, Alcorcon, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hopital Universitario Virgen de la Arrixaca, El palmar, , Spain
Hopital de Jerez (S.A.S), Jerez de la frontera, , Spain
Hospital de Leon, Leon, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Général Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario - La Paz, Madrid, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Hospital Central Asturias, Oviedo, , Spain
Hospital Clinico Salamanca, Salamanca, , Spain
Universitario Marques de Valdecilla, Santander, , Spain
Hospital Joan XXIII, Tarragona, , Spain
Hospital Mutua de Terrassa, Terrassa, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland