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Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP (REMARC)

23. juli 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

650

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Bendigo, Australien, 3550
        • Bendigo Hospital
      • Concord, Australien, 2139
        • Concord Repatriation General Hospital
      • Daw Park, Australien, 5000
        • Flinders Medical Centre - Repatriation General Hospital
      • Fitzroy, Australien, 3065
        • St Vincent's Hospital, Melbourne
      • Frankston, Australien, 3199
        • Frankston Hospital Monash Medical Centre
      • Fremantle, Australien, 6160
        • Fremantle Hospital
      • Garran, Australien, 2606
        • Canberra Hospital
      • Heidelberg, Australien, 69126
        • Austin Hospital
      • Hobart, Australien, 7000
        • Royal Hobart Hospital
      • Hunter, Australien, 2310
        • Mater Misericordiae Hospital - Calvary Mater NewCastle
      • Kogarah, Australien, 2217
        • St George Hospital
      • Nedlands, Australien, 6009
        • Sir Charles Gardiner Hospital
      • Southport, Australien, 4215
        • Gold Coast Hospital
      • Wodonga, Australien, 3690
        • Albury Base Hospital/Murray Valley Private Hospital
      • Woodville, Australien, 5011
        • Queen Elizabeth Hospital
  • Belgien
      • Antwerpen, Belgien, 2020
        • ZNA Middelheim
      • Antwerpen, Belgien, 2060
        • ZNA Stuivenberg
      • Arlon, Belgien, 6700
        • Hôpital Saint Joseph
      • Bruges, Belgien, 8000
        • A.Z. Sint Jan AV
      • Bruxelles, Belgien
        • Institut Jules Bordet
      • Bruxelles, Belgien, 1020
        • CHU Brugmann
      • Bruxelles, Belgien
        • Université Catholique de Louvain Saint Luc
      • Charleroi, Belgien, 6000
        • CH Notre Dame
      • Charleroi, Belgien, B-6000
        • CHU Charleroi-Vesale
      • Chimay, Belgien, 6460
        • Centre de Sante des Fagnes
      • Gent, Belgien, 9000
        • Universitair Ziekenhuis Gent
      • Gosselies, Belgien, 6041
        • Clinique Notre Dame de Grâce
      • HUY, Belgien, 4500
        • CH Hutois
      • Haine saint paul, Belgien, 7100
        • Hopital Jolimont
      • Jette, Belgien, 1090
        • AZ VUB
      • Kortrijk, Belgien, 8500
        • AZ Groeninge - Campus Maria s Voorzienigheid
      • Liege, Belgien, 4000
        • CHR de la Citadelle
      • Liege, Belgien, 4000
        • CHU de Liège
      • Mons, Belgien, 7000
        • CHU Ambroise Pare
      • Mons, Belgien, 7000
        • Clinique Saint Joseph
      • Namur, Belgien, 5000
        • Hopital Sainte Elisabeth
      • Ottignies, Belgien, 1340
        • Clinique Saint Pierre
      • Roeselare, Belgien, 8800
        • Heilig Hart Ziekenhuis
      • Verviers, Belgien, 4800
        • CH de la Tourelle-Peltzer
      • Wilrijk, Belgien, 2610
        • A.Z. Sint-Augustinus
      • Yvoir, Belgien, 5530
        • Universite Catholique de Louvain Mont Godinne
  • Frankrig
      • Annecy Cedex, Frankrig, 74011
        • CHR de la Région d'Annecy
      • Antibes, Frankrig, 06606
        • CH Antibes-Juan les Pins
      • Arras Cedex, Frankrig, 62022
        • CH d'Arras
      • Avignon, Frankrig, 84902
        • Hôpital Henri Duffaut
      • BONDY Cedex, Frankrig, 93143
        • Hôpital Jean Verdier
      • Bayonne, Frankrig, 64100
        • Hopital de Bayonne
      • Blois, Frankrig, 41016
        • CHG Mail Pierre Charlot
      • Bobigny, Frankrig, 93009
        • Hôpital d'Avicenne
      • Bordeaux, Frankrig, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Boulogne sur Mer, Frankrig, 62200
        • Hôpital Duchenne
      • Bourg-en-Bresse, Frankrig, 01012
        • CH de BOURG-EN-BRESSE
      • Brive-La-Gaillarde, Frankrig, 19100
        • Centre Hospitalier de Brive
      • CAEN Cedex 05, Frankrig, 14026
        • Centre Francois Baclesse
      • Caen Cedex, Frankrig, 14033
        • CHU Clémenceau- Côte de Nacre
      • Cannes, Frankrig, 06400
        • CH de Cannes
      • Chalon sur Saone, Frankrig, 711100
        • Hôpital de Chalon
      • Chambery, Frankrig, 73011
        • Centre hospitalier
      • Chartres Cedex, Frankrig, 28018 BP407
        • CH Chartres
      • Clamart, Frankrig, 92140
        • Hôpital Antoine Béclère
      • Clamart, Frankrig, 92140
        • Hôpital des instructions des Armées PERCY
      • Colmar Cedex, Frankrig, 68024
        • Hopital Louis Pasteur
      • Compiegne Cedex, Frankrig, 60321
        • Ch De Compiegne
      • Corbeil-Essonnes, Frankrig, 91108
        • Hôpital Sud Francilien
      • Créteil, Frankrig, 94010
        • CH Henri Mondor
      • Dijon, Frankrig, 21034
        • Chu Le Bocage
      • Dunkerque, Frankrig, 59385
        • CH de Dunkerque
      • Evreux, Frankrig, 27000
        • CHI Evreux
      • Frejus, Frankrig, 83608
        • CHI Frejus Saint Raphael
      • Grenoble, Frankrig, 38028
        • Institut Daniel Hollard
      • Gueret, Frankrig, 23000
        • Centre Hospitalier de Guéret
      • LE Mans, Frankrig, 72015
        • Clinique Victor Hugo - Centre Jean Bernard
      • LIMOGES Cedex, Frankrig, 87042
        • Hopital Dupuytren
      • LYON Cedex 08, Frankrig, 69373
        • Centre Leon Berard
      • La Rochelle Cedex 01, Frankrig, 17019
        • CHG La Rochelle
      • Le Chesnay, Frankrig, 78150
        • Hôpital André Mignot
      • Le Kremlin-Bicêtre, Frankrig, 94275
        • Hôpital Bicêtre
      • Lens, Frankrig, 62307
        • CHU de Lens
      • Lille, Frankrig, 59020
        • Hopital Saint Vincent de Paul
      • Lille Cedex, Frankrig, 59037
        • CHRU de Lille
      • Lyon, Frankrig, 69337
        • Clinique de la Sauvegarde
      • MELUN Cedex, Frankrig, 77011
        • CH Marc Jacquet
      • MULHOUSE Cedex, Frankrig, 68070
        • Hopital Emile Muller- CHU Mulhouse
      • Macon Cedex, Frankrig, 71018
        • CH les CHANAUX
      • Marseille, Frankrig, 13915
        • Hôpital Nord
      • Marseille Cedex, Frankrig, 13273
        • Institut Paoli Calmettes
      • Meaux, Frankrig, 77100
        • CHG Meaux
      • Metz Cedex, Frankrig, 57038
        • Hôpital Notre Dame de Bon Secours
      • Montpellier Cedex, Frankrig, 34298
        • CRLC Val d'Aurelle
      • Mougins, Frankrig, 062250
        • Centre Azuréen de Cancérologie
      • Neuilly sur seine, Frankrig, 92202
        • Hôpital Américain de Paris
      • Nice, Frankrig, 06189
        • Centre Antoine Lacassagne
      • Nice, Frankrig, 06202
        • CHU de Nice
      • Paris, Frankrig, 75012
        • Hôpital Saint Antoine
      • Paris, Frankrig, 75743
        • Hôpital Necker
      • Paris, Frankrig, 75475
        • Hopital St-Louis
      • Paris Cedex 04, Frankrig, 75181
        • Hotel Dieu
      • Paris Cedex 05, Frankrig, 75248
        • Institut Curie
      • Paris Cedex 13, Frankrig, 75651
        • Hôpital de la Pitié Salpêtrière
      • Perpignan, Frankrig, 66046
        • CH de Perpignan
      • Pierre Bénite Cedex, Frankrig, 64495
        • Centre Hospitalier Lyon Sud
      • Pontoise, Frankrig, 95303
        • CH René Dubos
      • REIMS Cedex, Frankrig, 51092
        • Hopital Robert Debre
      • Rouen, Frankrig, 76038
        • Centre Henri Becquerel
      • Rouen, Frankrig, 76175
        • Clinique Mathilde
      • Saint Cloud Cedex, Frankrig, 92211
        • Centre Rene Huguenin
      • St Germain en Laye, Frankrig, 78105
        • CHG Saint Germain
      • Toulon, Frankrig, 83056
        • CHI Toulon La Seyne-sur-mer
      • Toulouse Cedex 9, Frankrig, 31059
        • CHU Purpan Pav. Dieulafoy
      • Troyes Cedex, Frankrig, 10000
        • Hopital de Troyes
      • VILLEJUIF Cedex, Frankrig, 94805
        • Institut Gustave Roussy
      • Valence Cedex 9, Frankrig, 26953
        • CH VALENCE
      • Valenciennes, Frankrig, 59322
        • Ch de Valenciennes
      • Vandœuvre-lès-Nancy, Frankrig, 54511
        • CHU Nancy Brabois
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
      • Beer sheva, Israel, 84101
        • Soroka
      • Haifa, Israel, 31048
        • Bnai-Zion Medical Center
      • Kfar saba, Israel, 44281
        • Meir Medical Center
      • Petah Tikwah, Israel, 49100
        • Rabin Medical Center - Beilinson Hospital
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
  • Polen
      • Chorzow, Polen, 41500
        • SPZOZ Zespol Szpitali Miejskich w Chorzowie
      • Krakow, Polen, 31501
        • Klinika Hematologii Collegium Medicum UJ
      • Lodz, Polen, 93509
        • Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny
      • Warsaw, Polen, 02776
        • Medical University of Warsaw
      • Warszawa, Polen, 02781
        • Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii
  • Portugal
      • Coimbra, Portugal, 3000 - 075
        • Hospitais da universidade de Coimbra
      • Lisboa, Portugal, 1099 - 023
        • Instituto Português de Oncologia de Lisboa de Francisco Gentil
      • Lisboa, Portugal, 1649 - 035
        • Hospital de Santa Maria
      • Porto, Portugal, 4200
        • IPO - Francisco Gentil - Porto
  • Schweiz
      • Lausanne, Schweiz, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • Spanien
      • A coruna, Spanien, 15006
        • Complejo Hospitalario Universitario de A Coruña
      • Alcorcon, Spanien, 28922
        • Hospital Universitario Fundacion Alcorcón
      • Barcelona, Spanien, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spanien, 08036
        • Hospital Clinic Barcelona
      • El palmar, Spanien, 30120
        • Hopital Universitario Virgen de la Arrixaca
      • Jerez de la frontera, Spanien, 11407
        • Hopital de Jerez (S.A.S)
      • Leon, Spanien, 24080
        • Hospital de Leon
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spanien, 28003
        • Hospital 12 de Octubre
      • Madrid, Spanien, 28046
        • Hospital Universitario - La Paz
      • Murcia, Spanien, 30008
        • Hospital Morales Meseguer
      • Oviedo, Spanien, 33006
        • Hospital Central Asturias
      • Salamanca, Spanien, 37007
        • Hospital Clinico Salamanca
      • Santander, Spanien, 39008
        • Universitario Marques de Valdecilla
      • Tarragona, Spanien, 43007
        • Hospital Joan XXIII
      • Terrassa, Spanien, 08221
        • Hospital Mútua de Terrassa
  • Østrig
      • Feldkirch, Østrig, 6807
        • LKH Feldkirch
      • Innsbruck, Østrig, 6020
        • Medizinische Universität Innsbruck für Innere Medizin
      • Leoben, Østrig, 8700
        • LKH Leoben-Eisenerz Department für Hämato-Onkologie
      • Linz, Østrig, 4010
        • Krankenhaus der Elisabethinen Linz GmbH
      • Linz, Østrig, 4010
        • Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner
      • Linz, Østrig, 4021
        • AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un
      • Salzburg, Østrig, 5020
        • Universitätklinik der PMU Salzburg - Für Innere Medizin III
      • Steyr, Østrig, 4400
        • Landeskrankenhaus Steyr - Innere Medizin II
      • Vienna, Østrig, A-1090 VIE
        • Uniersitätsklinik f. Innere Medizin I
      • Wels, Østrig, 4600
        • Klinikum Wels-Grieskirchen GmbH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lenalidomide
Lenalidomide daily for 3 weeks every 4 weeks for 24 months
Medicin: Lenalidomide
Daily for 3 weeks every 4 weeks for 24 months
Andre navne:
  • Revlimid
Placebo komparator: Placebo
Placebo daily for 3 weeks every 4 weeks for 24 months
Medicin: Placebo
Daily for 3 weeks every 4 weeks for 24 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free-Survival (PFS)
Tidsramme: 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.
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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: 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
5 years
Event-Free Survival (EFS)
Tidsramme: 5 years
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
5 years
Response rate at the end of maintenance treatment
Tidsramme: 24 months
24 months
Percentage of patients who convert from PR (partial response) to CR (complete response)
Tidsramme: 24 months
24 months
Safety of lenalidomide in maintenance
Tidsramme: 5 years
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
5 years
PFS2
Tidsramme: 5 years
From randomization to objective tumor progression on next-line treatment or death from any cause
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Lymphoma Academic Research Organisation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. september 2019

Datoer for studieregistrering

Først indsendt

8. april 2010

Først indsendt, der opfyldte QC-kriterier

12. maj 2010

Først opslået (Skøn)

13. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REMARC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lenalidomide

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Sponsorer og samarbejdspartnere

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CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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