⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

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.

Trial Identification

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

Interventions

Lenalidomide
Placebo

Study Description

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.

Eligibility

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: