Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma

Who is this study for? Patients with Mantle Cell Lymphoma
Status: Completed
Location: See all (143) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

⁃ Signed informed consent form Biopsy-proven MCL according to WHO classification

⁃ ≥ 60 years of age and ineligible for autologous transplant Ann Arbor stage II-IV Previously untreated ECOG PS ≤ 2

⁃ Male subjects must:

• agree to use a condom during sexual contact with a woman of childbearing potential, even if they have had a vasectomy, throughout lenalidomide therapy

• agree to not donate semen during lenalidomide therapy.

⁃ All subjects must:

• have an understanding that the lenalidomide could have a potential teratogenic risk.

• agree to abstain from donating blood while taking lenalidomide therapy

• agree not to share study medication with another person.

• be counselled about pregnancy precautions and risks of foetal exposure.

⁃ Additional criteria for randomization in maintenance phase:

• CR, CRu or PR after induction treatment, determined as per Cheson 1999 criteria

• During the run-in period of 6 months starting from the date of the first randomization in the trial: in case of direct randomization into maintenance phase, patient must have been treated in first line by 6-8 cycles of R-CHOP.

Locations
Other Locations
Belgium
ZNA Stuivenberg
Antwerp
A. Z. Sint-Jan
Bruges
Institut Jules Bordet
Brussels
Université Catholique de Louvain Saint Luc
Brussels
Grand Hopital de Charleroi
Charleroi
AZ Groeninge
Kortrijk
CHU de Liège
Liège
CH de la Tourelle-Peltzer
Verviers
Université Catholique de Louvain Mont Godinne
Yvoir
France
CHU d'Amiens
Amiens
CHU d'Angers
Angers
CH d Avignon - Hopital Henri Duffaut
Avignon
CH Côte Basque
Bayonne
CHU Jean Minjoz
Besançon
CH de Blois
Blois
Institut Bergonié
Bordeaux
Polyclinique Bordeaux Nord
Bordeaux
CH du Dr Duchenne
Boulogne-sur-mer
CHU Morvan
Brest
CHU Caen
Caen
MEDIPOLE de SAVOIE
Challes-les-eaux
CHU de Châlon-sur-Sâone - William Morey
Châlon-sur-sâone
CH Chambéry
Chambéry
Hopital Antoine Beclere
Clamart
CHU Estaing
Clermont-ferrand
Pôle Santé République
Clermont-ferrand
CH Sud Francilien de Corbeil
Corbeil-essonnes
Hopital Henri Mondor
Créteil
CHU Le Bocage
Dijon
CH Dunkerque
Dunkirk
CHU de Grenoble
Grenoble
Institut Daniel Hollard
Grenoble
CH Départemental
La Roche-sur-yon
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle
Hôpital André Mignot
Le Chesnay
CH du Mans
Le Mans
Clinique Victor Hugo
Le Mans
CH de Lens
Lens
CHU Claude Hurriez
Lille
Centre Leon Berard
Lyon
Institut Paoli Calmette
Marseille
CH de Meaux
Meaux
Hôpital Bon Secours
Metz
CH de la Région Annecy-Genevois
Metz-tessy
CHU Montpellier
Montpellier
CHU Hôtel Dieu
Nantes
CHR de la Source
Orléans
Hôpital de la Pitié Salpêtrière
Paris
Hôpital Necker
Paris
Hopital Saint Antoine
Paris
Hôpital Saint Louis
Paris
CH Perpignan
Perpignan
Hôpital Haut Lévêque
Pessac
CHU Lyon Sud
Pierre-bénite
CH de Quimper Cornouaille
Quimper
CHU Robert Debre
Reims
CHU Pontchaillou
Rennes
Centre Henri Becquerel
Rouen
Institut de cancérologie de la Loire
Saint-priest-en-jarez
CH Saint Quentin
Saint-quentin
CHU de Strasbourg
Strasbourg
CHU Purpan
Toulouse
CHU Bretonneau
Tours
CHU Nancy Brabois
Vandœuvre-lès-nancy
Institut Gustave Roussy
Villejuif
Germany
Gesundheitszentrum St. Marien GmbH
Amberg
Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin
Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin
Städt. Klinikum Braunschweig gGmbH
Braunschweig
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Bremen
Klinikum Chemnitz gGmbH
Chemnitz
Universitätsklinikum Köln
Cologne
Marien Hospital Düsseldorf
Düsseldorf
St. Antonius Hospital
Eschweiler
Universitätsklinikum Essen
Essen
Klinikum Frankfurt GmbH
Frankfurt (oder)
Universitätsmedizin Greifswald
Greifswald
Kath. Krankenhaus Hagen gem. GmbH
Hagen
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Klinikum Herford
Herford
Universitätsklinikum des Saarlandes
Homburg/saar
Städt. Klinikum Karlsruhe
Karlsruhe
Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel
Kiel
Internistische Praxis /Hämatologie und Onkologie
Kronach
Onkologisches Zentrum - Lebach
Lebach
Klinikum Ludwigshafen
Ludwigshafen
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)
Mönchengladbach
Klinikum der Universität München
München
Klinikum rechts der Isar der TU München
München
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster
Universitätsklinikum Münster
Münster
Stauferklinikum Schwäbisch Gmünd
Mutlangen
Gemeinschaftspraxis für Hämatologie und internistische Onkologie
Neumarkt
Klinikum Nürnberg
Nuremberg
Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie
Offenbach
Brüderkrankenhaus St. Josef Paderborn
Paderborn
Universitätsklinik Rostock
Rostock
Mutterhaus der Borromäerinnen GmbH
Trier
University Hospital Tübingen
Tübingen
Universitätsklinikum Ulm
Ulm
Netherlands
Jeroen Bosch ziekenhuis
's-hertogenbosch
MC Alkmaar
Alkmaar
AMC
Amsterdam
OLVG
Amsterdam
VUMC
Amsterdam
Amphia ziekenhuis, locatie Langendijk
Breda
Reinier de Graaf Gasthuis
Delft
Gemini Ziekenhuis
Den Helder
Medisch Spectrum Twente
Enschede
Zuyderland MC
Geleen
Admiraal De Ruyter Ziekenhuis, Goes
Goes
Groene Hart Ziekenhuis
Gouda
UMCG
Groningen
Spaarne ziekenhuis
Hoofddorp
MC Leeuwarden Zuid
Leeuwarden
Maastricht UMC
Maastricht
Sint Antonius Ziekenhuis
Nieuwegein
Radboudumc
Nijmegen
Bravis ziekenhuis
Roosendaal
Erasmus MC - Centrum
Rotterdam
Erasmus MC - Daniel
Rotterdam
Maasstadziekenhuis
Rotterdam
Hagaziekenhuis, locatie Leyweg
The Hague
St.Elisabeth ZH
Tilburg
Isala Klinieken, Sophia
Zwolle
Poland
Gdansk University School of Medicine
Gdansk
Szpitale Wojewódzkie
Gdynia
University Hospital
Krakow
Warminsko-Mazurskie Centrum Onkologii
Olsztyn
Institute of Hematology and Transfusiology
Warsaw
MSCM Institute and Oncology Centre
Warsaw
Portugal
Instituto Português de Oncologia de Lisboa de Francisco Gentil
Lisbon
Spain
Hospital Universitario Fundación Alcorcón
Alcorcón
Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol
Badalona
Hospital Clínic
Barcelona
Hospital Universitario Vall d'hebron
Barcelona
Hospital San Pedro de Alcántara
Cáceres
Hospital Ramón y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Central de Asturias
Oviedo
Clínica Universidad de Navarra
Pamplona
Hospital Clínico de Salamanca
Salamanca
Hospital Clinico de Valencia
Valencia
Time Frame
Start Date: 2013-11
Completion Date: 2025-01-31
Participants
Target number of participants: 623
Treatments
Experimental: Induction experimental arm
R-CHOP / R-HAD : Alternating 3 cycles of R-CHOP administered in 3 week cycles + 3 cycles of R-HAD administered in 4 week cycles.
Active_comparator: Standart induction arm
8 cycles of R-CHOP administered in 3 week cycles
Experimental: Maintenance experimental arm
lenalidomide + rituximab : 13 cycles of rituximab SC 1400 mg administered in 8 week cycles + 26 cycles Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
Active_comparator: Maintenance standart arm
13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
Authors
Alejandro Martin, Hassan FARHAT, Reda BOUABDALLAH, Alain DELMER, Ullrich Graeven, Jean GABARRE, Jochen Greiner, Bachra CHOUFI, Catherine THIEBLEMONT, Martin Bentz, Stephan Stilgenbauer, Christiane MOUNIER, Cécile LEYRONNAS, Franck MORSCHHAUSER, Peter Staib, Guillaume CARTRON, Vincent RIBRAG, Rémy GRESSIN, Corinne HAIOUN, Claudio Denzlinger, Christiane Pott, Martina Stauch, Stephan Kremers, Steven LE GOUILL, Georg Lenz, Richard DELARUE, Rolf Mahlberg, Olivier FITOUSSI, Judith Dierlamm, Pierre FEUGIER, Anna SCHMITT, Johannes Kullmer, Borhane SLAMA, Omar BENBRAHIM, Tobias Gaska, Holger Hebart, Jean Pierre MAROLLEAU, Victoria CACHEUX, Marc ANDRE, Anne BANOS, Jean FONTAN, Maya HACINI, Nicolas DAGUINDAU, Ralf Trappe, Selim Corm, Jürgen Krauter, Hervé TILLY, Adrian TEMPESCUL, Kamel LARIBI, Mathias Hänel, Martin Dreyling, Jamilé FRAYFER, Christophe BONNET, Hervé MAISONNEUVE, Zora MARJANOVIC, Josef Birkmann, Martin Sökler, Kai Hübel, Rüdiger Liersch, Ulrich Keller, Caroline DARTIGEAS, Jan Dürig, Christophe FRUCHART, Lucie OBERIC, Bertrand JOLY, Laurence SANHES, Tobias Overbeck, Gilles SALLES, Jean-Michel PIGNON, Aleksander Skotnicki, Bea TANIS, Hein Visser, Michael Pfreundschuh, Pierre ZACHEE, Hans-Walter Lindemann, Harry SCHOUTEN, Juan Manuel Sancho, Marie-Pierre MOLES, Marie MAEREVOET, François BOUE, Lara BOHMER, Aart BEEKER, Wanda Knopinska-Posluszny, Marc DURIAN, Andrzej Hellmann, Sylvia SNAUWAERT, Carlos Panizo, Mels HOOGENDOORN, Antonio Pezzutto, Tjeerd SNIJDERS, Michal Taszner, Olivier CASASNOVAS, Wendy Stevens, Rineke Leys, Marcel Nijland, Jan Maciej Zaucha, Sebastian Grosicki, Carlos Grande, Roel VAN KAMPEN, Hans PRUIJT, Christian Andreas Schmidt, Rolf BROUWER, Luc-Matthieu FORNECKER, Maria José Terol, Martin Hoffmann, Jeanette Doorduijn, Jan Walewski, Norbert Schmitz, Krimo BOUABDALLAH, Josephine VOS, Marie José KERSTEN
Sponsors
Leads: The Lymphoma Academic Research Organisation

This content was sourced from clinicaltrials.gov

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