Last updated on March 2019

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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Gemini Ziekenhuis

Den Helder, Netherlands
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Radboudumc

Nijmegen, Netherlands
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CHU Purpan

Toulouse, France
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Erasmus MC - Centrum

Rotterdam, Netherlands
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Sint Antonius Ziekenhuis

Nieuwegein, Netherlands
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H pital Saint Louis

Paris cedex 10, France
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CH D partemental

La Roche Sur Yon, France
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Institut Daniel Hollard

GRENOBLE Cedex 1, France
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MC Alkmaar

Alkmaar, Netherlands
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CHU de Li ge

Liège, Belgium
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AZ Groeninge

Kortrijk, Belgium
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Spaarne ziekenhuis

Hoofddorp, Netherlands
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Maastricht UMC

Maastricht, Netherlands
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CH Dunkerque

Dunkerque, France
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AMC

Amsterdam, Netherlands
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UMCG

Groningen, Netherlands
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ZNA Stuivenberg

Antwerpen, Belgium
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Erasmus MC - Daniel

Rotterdam, Netherlands
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Bravis ziekenhuis

Roosendaal, Netherlands
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CH Chamb ry

Chambery, France
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St.Elisabeth ZH

Tilburg, Netherlands
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P le Sant R publique

CLERMONT FERRAND Cedex 2, France
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Klinikum Ludwigshafen

Ludwigshafen, Germany
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MC Leeuwarden Zuid

Leeuwarden, Netherlands
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CHU d'Amiens

AMIENS Cedex 1, France
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CH du Dr Duchenne

BOULOGNE SUR MER Cedex, France
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MEDIPOLE de SAVOIE

Challes les Eaux, France
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CHU Estaing

Clermont Ferrand, France
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CH du Mans

Le Mans, France
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Centre Leon Berard

Lyon Cedex 8, France
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CHU Montpellier

MONTPELLIER Cedex 5, France
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CHR de la Source

ORLEANS cedex 2, France
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CH Perpignan

Perpignan, France
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CH Saint Quentin

Saint Quentin, France
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CHU Nancy Brabois

Vandoeuvre Les Nancy, France
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Klinikum Frankfurt GmbH

Frankfurt (Oder), Germany
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VUMC

Amsterdam, Netherlands
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OLVG

Amsterdam, Netherlands
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Maasstadziekenhuis

Rotterdam, Netherlands
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Zuyderland MC

Geleen, Netherlands
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CHU Lyon Sud

Pierre Bénite cedex, France
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Recruitment Status: Open


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