Last updated on March 2018

R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL


Brief description of study

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).

Detailed Study Description

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 versus R-CHOP alone in older patients ( 60 year old) with mantle cell lymphoma. 643 patients will be randomized in induction phase and 433 in maintenance phase.

The treatments consist of two phases:

  • induction treatment will be 3 cycles of R-CHOP21 + 3 cycles of R-HAD28(alternating) versus 8 cycles of R-CHOP21 alone
  • maintenance treatment will be 13 cycles of rituximab every 8 weeks + 26 cycles of lenalidomide every 4 weeks vs 13 cycles of rituximab every 8 weeks.

Patients will be followed 2.5 years after the last patient randomized for maintenance for final analysis. All subjects who complete or discontinue the maintenance treatment for any reason will be followed for at least 3 years after his/her last study treatment administration in maintenance period for Second Primary Malignancies (SPM). A long term follow-up for progression/death will be done up to the end of period of SPM data collection.

Clinical Study Identifier: NCT01865110

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Pierre ZACHEE, MD

ZNA Stuivenberg
Antwerpen, Belgium
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Sylvia SNAUWAERT, MD

A. Z. Sint-Jan
Bruges, Belgium
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Marie MAEREVOET, MD

Institut Jules Bordet
Bruxelles, Belgium
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Eric VAN DEN NESTE, MD

Universit Catholique de Louvain Saint Luc
Bruxelles, Belgium
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Delphine PRANGER, MD

Grand Hopital de Charleroi
Charleroi, Belgium
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Koenraad VAN EYGEN, MD

AZ Groeninge
Kortrijk, Belgium
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Gaëtan VANSTRAELEN, MD

CH de la Tourelle-Peltzer
Verviers, Belgium
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Marc ANDRE, MD

Universit Catholique de Louvain Mont Godinne
Yvoir, Belgium
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Jean Pierre MAROLLEAU, Professor

CHU d'Amiens
AMIENS Cedex 1, France
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Marie-Pierre MOLES, Doctor

CHU d'Angers
Angers, France
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Borhane SLAMA, doctor

CH d Avignon - Hopital Henri Duffaut
Avignon Cedex 9, France
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Anne BANOS, doctor

CH C te Basque
Bayonne, France
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Jean FONTAN, MD

CHU Jean Minjoz
Besancon, France
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Anna SCHMITT, MD

Institut Bergoni
Bordeaux, France
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Olivier FITOUSSI, doctor

Polyclinique Bordeaux Nord
Bordeaux, France
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Bachra CHOUFI, doctor

CH du Dr Duchenne
BOULOGNE SUR MER Cedex, France
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Adrian TEMPESCUL, Doctor

CHU Morvan
Brest, France
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Selim Corm

MEDIPOLE de SAVOIE
Challes les Eaux, France
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Maya HACINI, Doctor

CH Chamb ry
Chambery, France
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François BOUE, Professor

Hopital Antoine Beclere
Clamart, France
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Joël FLEURY, Doctor

P le Sant R publique
CLERMONT FERRAND Cedex 2, France
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Victoria CACHEUX, Doctor

CHU Estaing
Clermont Ferrand, France
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Corinne HAIOUN, Professor

Hopital Henri Mondor
Creteil, France
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Olivier CASASNOVAS, Doctor

CHU Le Bocage
Dijon, France
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Jean-Michel PIGNON, Doctor

CH Dunkerque
Dunkerque, France
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Cécile LEYRONNAS, Doctor

Institut Daniel Hollard
GRENOBLE Cedex 1, France
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Rémy GRESSIN, Doctor

CHU de Grenoble
Grenoble, France
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Hervé MAISONNEUVE, Doctor

CH D partemental
La Roche Sur Yon, France
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Hassan FARHAT, MD

H pital Andr Mignot
Le Chesnay, France
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Kamel LARIBI, Doctor

CH du Mans
Le Mans, France
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Katell LE DÛ, Doctor

Clinique Victor Hugo
Le Mans, France
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Daniela ROBU, doctor

CH de Lens
Lens, France
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Franck MORSCHHAUSER, Doctor

CHU Claude Hurriez
Lille, France
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Emmanuelle NICOLAS- VIRELIZIER, Doctor

Centre Leon Berard
Lyon Cedex 8, France
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Reda BOUABDALLAH, doctor

Institut Paoli Calmette
Marseille, France
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Jamilé FRAYFER, Doctor

CH de Meaux
Meaux, France
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Nicolas DAGUINDAU, Doctor

CH de la R gion Annecy-Genevois
Metz-Tessy, France
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Philippe CARASSOU, Doctor

H pital Bon Secours
Metz, France
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Guillaume CARTRON, Professor

CHU Montpellier
MONTPELLIER Cedex 5, France
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Steven LE GOUILL, Professor

CHU H tel Dieu
Nantes, France
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Omar BENBRAHIM, Doctor

CHR de la Source
ORLEANS cedex 2, France
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Catherine THIEBLEMONT, Professor

H pital Saint Louis
Paris cedex 10, France
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Zora MARJANOVIC, Doctor

Hopital Saint Antoine
Paris, France
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Jean GABARRE, doctor

H pital de la Piti Salp tri re
Paris, France
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Richard DELARUE, doctor

H pital Necker
Paris, France
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Laurence SANHES, Doctor

CH Perpignan
Perpignan, France
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Krimo BOUABDALLAH, Doctor

H pital Haut L v que
Pessac, France
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Alain DELMER, Doctor

CHU Robert Debre
Reims, France
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Thierry LAMY de la CHAPELLE, ...

CHU Pontchaillou
Rennes, France
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Hervé TILLY, Professor

Centre Henri Becquerel
Rouen, France
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Réda GARIDI, Doctor

CH Saint Quentin
Saint Quentin, France
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Christiane MOUNIER, Professor

Institut de canc rologie de la Loire
St priest en jarez, France
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Luc-Matthieu FORNECKER, Doctor

CHU de Strasbourg
Strasbourg, France
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Lucie OBERIC

CHU Purpan
Toulouse, France
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Caroline DARTIGEAS, doctor

CHU Bretonneau
Tours, France
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Pierre FEUGIER, Professor

CHU Nancy Brabois
Vandoeuvre Les Nancy, France
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Vincent RIBRAG, doctor

Institut Gustave Roussy
Villejuif, France
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Ludwig Fischer v. Weikersthal, MD

Gesundheitszentrum St. Marien GmbH
Amberg, Germany
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Antonio Pezzutto, Prof.

Charite Universit tsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
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Andreas Loew, MD

Charite Universit tsmedizin Berlin Campus Virchow-Klinikum
Berlin, Germany
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Jürgen Krauter, Prof.

St dt. Klinikum Braunschweig gGmbH
Braunschweig, Germany
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Ralf Trappe, MD

DIAKO Ev. Diakonie-Krankenhaus gemeinn tzige GmbH
Bremen, Germany
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Mathias Hänel, MD

Klinikum Chemnitz gGmbH
Chemnitz, Germany
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Peter Staib, MD

St. Antonius Hospital
Eschweiler, Germany
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Jan Dürig, Prof.

Universit tsklinikum Essen
Essen, Germany
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Arkadius Gawliczek, MD

Klinikum Frankfurt GmbH
Frankfurt (Oder), Germany
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Christian Andreas Schmidt, Prof.

Universit tsmedizin Greifswald
Greifswald, Germany
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Hans-Walter Lindemann, MD

Kath. Krankenhaus Hagen gem. GmbH
Hagen, Germany
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Judith Dierlamm, Prof.

Universit tsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Stephan Bildat, MD

Klinikum Herford
Herford, Germany
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Michael Pfreundschuh, Prof

Universit tsklinikum des Saarlandes
Homburg/Saar, Germany
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Martin Bentz, Prof.

St dt. Klinikum Karlsruhe
Karlsruhe, Germany
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Christiane Pott, MD

Uni-Klinikum-Schleswig-Holstein im St dt. Krankenhaus Kiel
Kiel, Germany
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Martina Stauch, MD

Internistische Praxis /H matologie und Onkologie
Kronach, Germany
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Stephan Kremers, MD

Onkologisches Zentrum - Lebach
Lebach, Germany
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Martin Hoffmann, MD

Klinikum Ludwigshafen
Ludwigshafen, Germany
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Holger Hebart, Prof.

Stauferklinikum Schw bisch Gm nd
Mutlangen, Germany
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Ekkehart Ladda, MD

Gemeinschaftspraxis f r H matologie und internistische Onkologie
Neumarkt, Germany
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Hans-Peter Böck, MD

Gemeinschaftspraxis f r Innere Medizin, H matologie und internistische Onkologie
Offenbach, Germany
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Tobias Gaska, MD

Br derkrankenhaus St. Josef Paderborn
Paderborn, Germany
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Christina Große-Thie, MD

Universit tsklinik Rostock
Rostock, Germany
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Rolf Mahlberg, MD

Mutterhaus der Borrom erinnen GmbH
Trier, Germany
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Stephan Stilgenbauer, Prof.

Universit tsklinikum Ulm
Ulm, Germany
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Hein Visser

MC Alkmaar
Alkmaar, Netherlands
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Josée Zijlstra-Baalbergen, MD

VUMC
Amsterdam, Netherlands
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W Terpstra

OLVG
Amsterdam, Netherlands
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Marie José KERSTEN

AMC
Amsterdam, Netherlands
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Joost VAN ESSER

Amphia ziekenhuis, locatie Langendijk
Breda, Netherlands
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Rolf BROUWER

Reinier de Graaf Gasthuis
Delft, Netherlands
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Hans PRUIJT

Jeroen Bosch ziekenhuis
Den Bosch, Netherlands
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Lara BOHMER

Hagaziekenhuis, locatie Leyweg
Den Haag, Netherlands
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Arie VAN DER SPEK

Gemini Ziekenhuis
Den Helder, Netherlands
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Tjeerd SNIJDERS

Medisch Spectrum Twente
Enschede, Netherlands
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Yavuz BILGIN

Admiraal De Ruyter Ziekenhuis, Goes
Goes, Netherlands
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Bea TANIS

Groene Hart Ziekenhuis
Gouda, Netherlands
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Marcel Nijland

UMCG
Groningen, Netherlands
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Aart BEEKER

Spaarne ziekenhuis
Hoofddorp, Netherlands
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Mels HOOGENDOORN

MC Leeuwarden Zuid
Leeuwarden, Netherlands
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Harry SCHOUTEN

Maastricht UMC
Maastricht, Netherlands
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Josephine VOS

Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
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Wendy Stevens

Radboudumc
Nijmegen, Netherlands
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Nicole VAN DEN BURG-DE GRAAUW

Bravis ziekenhuis
Roosendaal, Netherlands
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Elly LUGTENBURG

Erasmus MC - Centrum
Rotterdam, Netherlands
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Jeanette Doorduijn

Erasmus MC - Daniel
Rotterdam, Netherlands
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Rineke Leys

Maasstadziekenhuis
Rotterdam, Netherlands
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Marc DURIAN

St.Elisabeth ZH
Tilburg, Netherlands
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Marinus VAN MARWIJK KOOY

Isala Klinieken, Sophia
Zwolle, Netherlands
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Bertrand JOLY, Doctor

CH Sud Francilien de Corbeil
Corbeil Essonnes, France
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Roel VAN KAMPEN

Zuyderland MC
Geleen, Netherlands
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Christophe BONNET, MD

CHU de Li ge
Liège, Belgium
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Gilles SALLES, Professor

CHU Lyon Sud
Pierre Bénite cedex, France
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Aristoteles GIAGOUNIDIS, MD

Marien Hospital D sseldorf
Düsseldorf, Germany
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Kai Hübel, Prof.

Universit tsklinikum K ln
Köln, Germany
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Ullrich Graeven, Prof.

Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)
Mönchengladbach, Germany
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Klinikum rechts der Isar der TU M nchen
München, Germany
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Martin Dreyling, Prof.

Klinikum der Universit t M nchen
München, Germany
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Rüdiger Liersch, MD

Gemeinschaftspraxis f r H matologie und Onkologie
Münster, Germany
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Universit tsklinikum M nster
Münster, Germany
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Klinikum N rnberg
Nürnberg, Germany
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Martin Sökler

University Hospital T bingen
Tübingen, Germany
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