Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
NCT ID: NCT01122472
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2009-04-30
2019-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lenalidomide
Lenalidomide daily for 3 weeks every 4 weeks for 24 months
Lenalidomide
Daily for 3 weeks every 4 weeks for 24 months
Placebo
Placebo daily for 3 weeks every 4 weeks for 24 months
Placebo
Daily for 3 weeks every 4 weeks for 24 months
Interventions
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Lenalidomide
Daily for 3 weeks every 4 weeks for 24 months
Placebo
Daily for 3 weeks every 4 weeks for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Accepts Healthy Volunteers: No
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 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
60 Years
80 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Locations
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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
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
Hopital Saint Joseph
Arlon, , Belgium
A.Z. Sint Jan AV
Bruges, , Belgium
CHU Brugmann
Brussels, , Belgium
Institut Jules BORDET
Brussels, , Belgium
Universite Catholique de Louvain Saint Luc
Brussels, , Belgium
CH Notre Dame
Charleroi, , Belgium
CHU Charleroi-Vesale
Charleroi, , Belgium
Centre de Sante des Fagnes
Chimay, , Belgium
Universitair Ziekenhuis Gent
Ghent, , 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
Liège, , Belgium
CHU de Liege
Liège, , 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, , France
CH Antibes-Juan les Pins
Antibes, , France
CH d'Arras
Arras, , 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, , 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, , France
CHU Clémenceau- Côte de Nacre
Caen, , France
CH de Cannes
Cannes, , France
Hôpital de Châlon
Chalon-sur-Saône, , France
Centre Hospitalier
Chambéry, , France
CH Chartres
Chartres, , France
Hopital Antoine Béclère
Clamart, , France
Hôpital des instructions des Armées PERCY
Clamart, , France
Hopital Louis Pasteur
Colmar, , France
CH de Compiègne
Compiègne, , France
Hopital Sud Francilien
Corbeil-Essonnes, , France
CH Henri Mondor
Créteil, , France
CHU le Bocage
Dijon, , France
CH de Dunkerque
Dunkirk, , France
CHI Evreux
Évreux, , France
CHI Fréjus Saint Raphaêl
Fréjus, , France
Institut Daniel Hollard
Grenoble, , France
Centre Hospitalier de Guéret
Guéret, , France
CHG La Rochelle
La Rochelle, , 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
Hôpital Saint Vincent de Paul
Lille, , France
CHRU de Lille
Lille, , France
Hopital DUPUYTREN
Limoges, , France
Clinique de la Sauvegarde
Lyon, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hopital Nord
Marseille, , France
CH les CHANAUX
Mâcon, , France
CHG Meaux
Meaux, , France
CH Marc JACQUET
Melun, , France
Hopital Notre Dame de Bon Secours
Metz, , France
CRLC Val d'Aurelle
Montpellier, , France
Centre Azuréen de Cancérologie
Mougins, , France
Hopital Emile Muller- CHU Mulhouse
Mulhouse, , France
Hôpital Américain de Paris
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
CHU de Nice
Nice, , France
Hopital Saint Antoine
Paris, , France
Hôtel Dieu
Paris, , France
Institut Curie
Paris, , France
Hopital St-Louis
Paris, , France
Hopital de la Pitié Salpetrière
Paris, , France
Hopital NECKER
Paris, , France
CH de Perpignan
Perpignan, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CH René DUBOS
Pontoise, , France
Hopital Robert DEBRE
Reims, , France
Centre Henri BECQUEREL
Rouen, , France
Clinique Mathilde
Rouen, , France
Centre René Huguenin
Saint-Cloud, , France
CHG Saint Germain
Saint-Germain-en-Laye, , France
CHI Toulon La Seyne-sur-mer
Toulon, , France
CHU Purpan Pav. Dieulafoy
Toulouse, , France
Hopital de Troyes
Troyes, , France
CH Valence
Valence, , France
CH de Valenciennes
Valenciennes, , France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave ROUSSY
Villejuif, , France
Haemek Medical Center
Afula, , Israel
Barzilai Medical Center
Ashkelon, , Israel
Soroka
Beersheba, , Israel
Bnai-Zion medical center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
SPZOZ Zespol Szpitali Miejskich w Chorzowie
Chorzów, , 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
Warsaw, , Poland
Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Instituto Português de Oncologia de Lisboa de Francisco Gentil
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
IPO - Francisco Gentil - Porto
Porto, , Portugal
Complejo Hospitalario Universitario de A Coruna
A Coruña, , Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, , 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
León, , 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
Countries
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References
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Beldi-Ferchiou A, Jais JP, Ghesquieres H, Casasnovas RO, Tilly H, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Perrot A, Nicolas-Virelizier E, Salles G, Godard N, Zamali I, De Colella JS, Claudel A, Corront B, Oberic L, Briere J, Gaulard P, Thieblemont C, Delfau-Larue MH. Lenalidomide maintenance fails to overcome the unfavourable prognosis of low NK-cell counts in rituximab-chemotherapy responsive elderly DLBCL patients: A LYSA group study. Br J Haematol. 2023 Apr;201(2):256-266. doi: 10.1111/bjh.18642. Epub 2023 Feb 6.
Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.
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.
Related Links
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Related Info
Other Identifiers
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REMARC
Identifier Type: -
Identifier Source: org_study_id
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