Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP (REMARC)
23 luglio 2021 aggiornato da: The Lymphoma Academic Research Organisation
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
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
650
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bendigo, Australia, 3550
- Bendigo Hospital
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Concord, Australia, 2139
- Concord Repatriation General Hospital
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Daw Park, Australia, 5000
- Flinders Medical Centre - Repatriation General Hospital
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Fitzroy, Australia, 3065
- St Vincent's Hospital, Melbourne
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Frankston, Australia, 3199
- Frankston Hospital Monash Medical Centre
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Fremantle, Australia, 6160
- Fremantle Hospital
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Garran, Australia, 2606
- Canberra Hospital
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Heidelberg, Australia, 69126
- Austin Hospital
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Hobart, Australia, 7000
- Royal Hobart Hospital
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Hunter, Australia, 2310
- Mater Misericordiae Hospital - Calvary Mater NewCastle
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Kogarah, Australia, 2217
- St George Hospital
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Nedlands, Australia, 6009
- Sir Charles Gardiner Hospital
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Southport, Australia, 4215
- Gold Coast Hospital
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Wodonga, Australia, 3690
- Albury Base Hospital/Murray Valley Private Hospital
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Woodville, Australia, 5011
- Queen Elizabeth Hospital
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Feldkirch, Austria, 6807
- LKH Feldkirch
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Innsbruck, Austria, 6020
- Medizinische Universität Innsbruck für Innere Medizin
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Leoben, Austria, 8700
- LKH Leoben-Eisenerz Department für Hämato-Onkologie
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Linz, Austria, 4010
- Krankenhaus der Elisabethinen Linz GmbH
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Linz, Austria, 4010
- Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner
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Linz, Austria, 4021
- AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un
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Salzburg, Austria, 5020
- Universitätklinik der PMU Salzburg - Für Innere Medizin III
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Steyr, Austria, 4400
- Landeskrankenhaus Steyr - Innere Medizin II
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Vienna, Austria, A-1090 VIE
- Uniersitätsklinik f. Innere Medizin I
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Wels, Austria, 4600
- Klinikum Wels-Grieskirchen GmbH
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Antwerpen, Belgio, 2020
- ZNA Middelheim
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Antwerpen, Belgio, 2060
- ZNA Stuivenberg
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Arlon, Belgio, 6700
- Hôpital Saint Joseph
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Bruges, Belgio, 8000
- A.Z. Sint Jan AV
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Bruxelles, Belgio
- Institut Jules Bordet
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Bruxelles, Belgio, 1020
- CHU Brugmann
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Bruxelles, Belgio
- Université Catholique de Louvain Saint Luc
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Charleroi, Belgio, 6000
- CH Notre Dame
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Charleroi, Belgio, B-6000
- CHU Charleroi-Vesale
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Chimay, Belgio, 6460
- Centre de Sante des Fagnes
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Gent, Belgio, 9000
- Universitair Ziekenhuis Gent
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Gosselies, Belgio, 6041
- Clinique Notre Dame de Grâce
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HUY, Belgio, 4500
- CH Hutois
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Haine saint paul, Belgio, 7100
- Hopital Jolimont
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Jette, Belgio, 1090
- AZ VUB
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Kortrijk, Belgio, 8500
- AZ Groeninge - Campus Maria s Voorzienigheid
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Liege, Belgio, 4000
- CHR de la Citadelle
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Liege, Belgio, 4000
- CHU de Liège
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Mons, Belgio, 7000
- CHU Ambroise Pare
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Mons, Belgio, 7000
- Clinique Saint Joseph
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Namur, Belgio, 5000
- Hopital Sainte Elisabeth
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Ottignies, Belgio, 1340
- Clinique Saint Pierre
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Roeselare, Belgio, 8800
- Heilig Hart Ziekenhuis
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Verviers, Belgio, 4800
- CH de la Tourelle-Peltzer
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Wilrijk, Belgio, 2610
- A.Z. Sint-Augustinus
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Yvoir, Belgio, 5530
- Universite Catholique de Louvain Mont Godinne
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Annecy Cedex, Francia, 74011
- CHR de la Région d'Annecy
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Antibes, Francia, 06606
- CH Antibes-Juan les Pins
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Arras Cedex, Francia, 62022
- CH d'Arras
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Avignon, Francia, 84902
- Hôpital Henri Duffaut
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BONDY Cedex, Francia, 93143
- Hôpital Jean Verdier
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Bayonne, Francia, 64100
- Hopital de Bayonne
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Blois, Francia, 41016
- CHG Mail Pierre Charlot
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Bobigny, Francia, 93009
- Hôpital d'Avicenne
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Bordeaux, Francia, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Boulogne sur Mer, Francia, 62200
- Hôpital Duchenne
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Bourg-en-Bresse, Francia, 01012
- CH de BOURG-EN-BRESSE
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Brive-La-Gaillarde, Francia, 19100
- Centre Hospitalier de Brive
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CAEN Cedex 05, Francia, 14026
- Centre Francois Baclesse
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Caen Cedex, Francia, 14033
- CHU Clémenceau- Côte de Nacre
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Cannes, Francia, 06400
- CH de Cannes
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Chalon sur Saone, Francia, 711100
- Hôpital de Chalon
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Chambery, Francia, 73011
- Centre hospitalier
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Chartres Cedex, Francia, 28018 BP407
- CH Chartres
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Clamart, Francia, 92140
- Hôpital Antoine Béclère
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Clamart, Francia, 92140
- Hôpital des instructions des Armées PERCY
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Colmar Cedex, Francia, 68024
- Hopital Louis Pasteur
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Compiegne Cedex, Francia, 60321
- Ch De Compiegne
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Corbeil-Essonnes, Francia, 91108
- Hôpital Sud Francilien
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Créteil, Francia, 94010
- CH Henri Mondor
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Dijon, Francia, 21034
- Chu Le Bocage
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Dunkerque, Francia, 59385
- CH de Dunkerque
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Evreux, Francia, 27000
- CHI Evreux
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Frejus, Francia, 83608
- CHI Frejus Saint Raphael
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Grenoble, Francia, 38028
- Institut Daniel Hollard
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Gueret, Francia, 23000
- Centre Hospitalier de Guéret
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LE Mans, Francia, 72015
- Clinique Victor Hugo - Centre Jean Bernard
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LIMOGES Cedex, Francia, 87042
- Hopital Dupuytren
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LYON Cedex 08, Francia, 69373
- Centre Leon Berard
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La Rochelle Cedex 01, Francia, 17019
- CHG La Rochelle
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Le Chesnay, Francia, 78150
- Hôpital André Mignot
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Le Kremlin-Bicêtre, Francia, 94275
- Hôpital Bicêtre
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Lens, Francia, 62307
- CHU de Lens
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Lille, Francia, 59020
- Hopital Saint Vincent de Paul
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Lille Cedex, Francia, 59037
- CHRU de Lille
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Lyon, Francia, 69337
- Clinique de la Sauvegarde
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MELUN Cedex, Francia, 77011
- CH Marc Jacquet
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MULHOUSE Cedex, Francia, 68070
- Hopital Emile Muller- CHU Mulhouse
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Macon Cedex, Francia, 71018
- CH les CHANAUX
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Marseille, Francia, 13915
- Hôpital Nord
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Marseille Cedex, Francia, 13273
- Institut Paoli Calmettes
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Meaux, Francia, 77100
- CHG Meaux
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Metz Cedex, Francia, 57038
- Hôpital Notre Dame de Bon Secours
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Montpellier Cedex, Francia, 34298
- CRLC Val d'Aurelle
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Mougins, Francia, 062250
- Centre Azuréen de Cancérologie
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Neuilly sur seine, Francia, 92202
- Hôpital Américain de Paris
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Nice, Francia, 06189
- Centre Antoine Lacassagne
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Nice, Francia, 06202
- CHU de Nice
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Paris, Francia, 75012
- Hôpital Saint Antoine
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Paris, Francia, 75743
- Hôpital Necker
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Paris, Francia, 75475
- Hopital St-Louis
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Paris Cedex 04, Francia, 75181
- Hotel Dieu
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Paris Cedex 05, Francia, 75248
- Institut Curie
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Paris Cedex 13, Francia, 75651
- Hôpital de la Pitié Salpêtrière
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Perpignan, Francia, 66046
- CH de Perpignan
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Pierre Bénite Cedex, Francia, 64495
- Centre Hospitalier Lyon Sud
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Pontoise, Francia, 95303
- CH René Dubos
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REIMS Cedex, Francia, 51092
- Hopital Robert Debre
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Rouen, Francia, 76038
- Centre Henri Becquerel
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Rouen, Francia, 76175
- Clinique Mathilde
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Saint Cloud Cedex, Francia, 92211
- Centre Rene Huguenin
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St Germain en Laye, Francia, 78105
- CHG Saint Germain
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Toulon, Francia, 83056
- CHI Toulon La Seyne-sur-mer
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Toulouse Cedex 9, Francia, 31059
- CHU Purpan Pav. Dieulafoy
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Troyes Cedex, Francia, 10000
- Hopital de Troyes
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VILLEJUIF Cedex, Francia, 94805
- Institut Gustave Roussy
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Valence Cedex 9, Francia, 26953
- CH VALENCE
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Valenciennes, Francia, 59322
- Ch de Valenciennes
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Vandœuvre-lès-Nancy, Francia, 54511
- CHU Nancy Brabois
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Afula, Israele, 18101
- Haemek Medical Center
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Ashkelon, Israele, 78278
- Barzilai Medical Center
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Beer sheva, Israele, 84101
- Soroka
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Haifa, Israele, 31048
- Bnai-Zion Medical Center
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Kfar saba, Israele, 44281
- Meir Medical Center
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Petah Tikwah, Israele, 49100
- Rabin Medical Center - Beilinson Hospital
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Rehovot, Israele, 76100
- Kaplan Medical Center
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Chorzow, Polonia, 41500
- SPZOZ Zespol Szpitali Miejskich w Chorzowie
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Krakow, Polonia, 31501
- Klinika Hematologii Collegium Medicum UJ
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Lodz, Polonia, 93509
- Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny
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Warsaw, Polonia, 02776
- Medical University of Warsaw
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Warszawa, Polonia, 02781
- Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii
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Coimbra, Portogallo, 3000 - 075
- Hospitais da universidade de Coimbra
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Lisboa, Portogallo, 1099 - 023
- Instituto Português de Oncologia de Lisboa de Francisco Gentil
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Lisboa, Portogallo, 1649 - 035
- Hospital de Santa Maria
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Porto, Portogallo, 4200
- IPO - Francisco Gentil - Porto
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A coruna, Spagna, 15006
- Complejo Hospitalario Universitario de A Coruña
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Alcorcon, Spagna, 28922
- Hospital Universitario Fundacion Alcorcón
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Barcelona, Spagna, 08041
- Hospital De La Santa Creu I Sant Pau
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Barcelona, Spagna, 08036
- Hospital Clinic Barcelona
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El palmar, Spagna, 30120
- Hopital Universitario Virgen de la Arrixaca
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Jerez de la frontera, Spagna, 11407
- Hopital de Jerez (S.A.S)
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Leon, Spagna, 24080
- Hospital de Leon
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Madrid, Spagna, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spagna, 28003
- Hospital 12 de Octubre
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Madrid, Spagna, 28046
- Hospital Universitario - La Paz
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Murcia, Spagna, 30008
- Hospital Morales Meseguer
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Oviedo, Spagna, 33006
- Hospital Central Asturias
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Salamanca, Spagna, 37007
- Hospital Clinico Salamanca
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Santander, Spagna, 39008
- Universitario Marques de Valdecilla
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Tarragona, Spagna, 43007
- Hospital Joan XXIII
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Terrassa, Spagna, 08221
- Hospital Mútua de Terrassa
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Lausanne, Svizzera, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 60 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Ages Eligible for Study: Between 60 and 80 years old
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
For patients registered at the time of initial diagnosis
- Patient with histologically proven CD20+ diffuse large B cel LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
- previous untreated with chemo- or radiotherapy
For patients registered after response evaluation to first line treatment with R-CHOP:
- Patient with histologically proven CD20+ diffuse large B cell LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
- Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimens and up to 8 cycles of R-CHOP21
- Previously untreated with Radiotherapy
For all patients:
- aged from 60 to 80 years at time of registration
- Ann Arbor stages II-IV at time of initial diagnosis
- aaIPI> 1 at time of initial diagnosis
- ECOG performance status 0-2
- Minimum life expectancy of 3 months
Following laboratory values at screening:
- ANC≥ 1000.10^6/L and Platelets≥60000.10^6/L
- AST<5*ULN, ALT<5*ULN, Total Bilirubin<1,5*ULN
- Creatinine clearance>30mL/min
- Women are are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and after end of study. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
- Having previously signed a written informed consent form
Exclusion Criteria:
- Any other histological type of Lymphoma, Burkitt included.
- Any history of treated or non treated small B-cell lymphoma
- Central nervous system or meningeal involvement by lymphoma
- Contraindication to any drug contained in the chemotherapy regimen Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus as defined by the investigator
- Active systemic infection requiring treatment
- previously known HIV positive serology
- Active hepatitis B or C
- Prior history of malignancies other than lymphoma within 3 years
- Serious medical or psychiatric illness
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Lenalidomide
Lenalidomide daily for 3 weeks every 4 weeks for 24 months
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Daily for 3 weeks every 4 weeks for 24 months
Altri nomi:
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Comparatore placebo: Placebo
Placebo daily for 3 weeks every 4 weeks for 24 months
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Daily for 3 weeks every 4 weeks for 24 months
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression-Free-Survival (PFS)
Lasso di tempo: Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.
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PFS will be measured from the date of randomization to the date of first documented disease progression or death.
Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.
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Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall survival (OS)
Lasso di tempo: 5 years
|
From the date of randomization to the date of death from any cause Interim analysis of OS will be performed at the time of the PFS final analysis; it is projected to have 97 deaths at this time.
Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
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5 years
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Event-Free Survival (EFS)
Lasso di tempo: 5 years
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From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause Interim analysis of EFS will be performed at the time of the PFS final analysis.
Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
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5 years
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Response rate at the end of maintenance treatment
Lasso di tempo: 24 months
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24 months
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Percentage of patients who convert from PR (partial response) to CR (complete response)
Lasso di tempo: 24 months
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24 months
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Safety of lenalidomide in maintenance
Lasso di tempo: 5 years
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Toxicities occured during maintenance phase will be measured and reported from grade 2 for infection and neurological toxicities and from grade 3 for other toxicities according to CTCAE v3
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5 years
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PFS2
Lasso di tempo: 5 years
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From randomization to objective tumor progression on next-line treatment or death from any cause
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5 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CTdagger. Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3.
- Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, Lopez-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2009
Completamento primario (Effettivo)
1 giugno 2016
Completamento dello studio (Effettivo)
1 settembre 2019
Date di iscrizione allo studio
Primo inviato
8 aprile 2010
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2010
Primo Inserito (Stima)
13 maggio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 luglio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 luglio 2021
Ultimo verificato
1 luglio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma
- Linfoma, cellule B
- Linfoma, a grandi cellule B, diffuso
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Fattori immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Lenalidomide
Altri numeri di identificazione dello studio
- REMARC
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Lenalidomide
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Arbeitsgemeinschaft medikamentoese TumortherapieCelgene CorporationSconosciutoLeucemia Mielomonocitica CronicaAustria
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University Hopsital Schleswig Holstein Campus LübeckReclutamentoMieloma multiplo di nuova diagnosiGermania