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

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ClinicalTrials.gov Identifier: NCT01865110
Recruitment Status : Recruiting
First Posted : May 30, 2013
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Brief 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).


Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: R-CHOP Drug: R-CHOP / R-HAD Drug: Rituximab Drug: Lenalidomide Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.
Drug: R-CHOP / R-HAD
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) administered in 3 week cycles for 3 cycles R-HAD (rituximab, cytarabine, dexamethasone) administered in 3 week cycles for 4 cycles alternating
Other Names:
  • rituximab, CHOP
  • rituximab HD AraC

Active Comparator: Standart induction arm
8 cycles of R-CHOP administered in 3 week cycles
Drug: R-CHOP
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
Other Name: rituximab, CHOP

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
Drug: Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Other Name: Mabthera

Drug: Lenalidomide
Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
Other Name: Revlimid

Active Comparator: Maintenance standart arm
13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
Drug: Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Other Name: Mabthera




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2.5 years ]
    2.5 years after last patient randomized in maintenance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Female of childbearing potential

Any of the following laboratory abnormalities at diagnosis, if not related to lymphoma:

Absolute neutrophils count <1,000 /mm3 Platelet count < 75,000/mm3 AST/SGOT or ALT/SGPT >3.0 UNL Serum total bilirubin > 1.5 ULN (except if due to Gilbert's syndrome) Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) < 30 mL / min Central Nervous System involvement by lymphoma Contraindication for medical DVT prophylaxis for patients at high risk for DVT

Prior history of malignancies other than MCL unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:

  • Basal cell carcinoma or Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix or of the breast
  • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b). Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient to receive the study medication as planned.

Seropositivity for human immunodeficiency virus at study entry Seropositivity for hepatitis C virus at study entry,

Active viral infection with hepatitis B virus at study entry:

  • HBsAg positive
  • HBsAg negative, anti-HBs positive and anti-HBc positive

Uncontrolled illness including, but not limited to:

  • Active infection requiring parenteral antibiotics.
  • Uncontrolled diabetes mellitus
  • Chronic symptomatic congestive heart failure (Class NYHA III or IV).
  • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.

Prior ≥ Grade 3 allergic hypersensitivity to thalidomide. Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.

Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies.

Subjects with ≥ Grade 2 neuropathy. Prior use of lenalidomide Participation in another clinical trial within three weeks before randomization in this study

Additional criteria for randomization in maintenance phase:

  • SD or PD after induction treatment determined as per Cheson 1999 criteria
  • Patient treated by induction immuno-chemotherapy other than 6-8 cycle of R-CHOP21 or 2-3 cycles of R-CHOP21 / 2-3 cycles of R-HAD28 (alternating)
  • Patients with serious underlying medical conditions, which could impair the ability to receive maintenance treatment
  • Calculated creatinine clearance of < 30 mL / min
  • ANC is < 1,000 cells/mm³
  • Platelet count is < 50,000 cells/mm³

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865110


Contacts
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Contact: Christine STEPHAN +33 4 72 66 93 33 christine.stephan@lysarc.org

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Locations
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Belgium
ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Pierre ZACHEE, MD       pierre.zachee@zna.be   
Principal Investigator: Pierre ZACHEE, MD         
A. Z. Sint-Jan Recruiting
Bruges, Belgium, 8000
Contact: Sylvia SNAUWAERT, MD       Sylvia.snauwaert@azsintjan.be   
Principal Investigator: Sylvia SNAUWAERT, MD         
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Contact: Marie MAEREVOET, MD       marie.maerevoet@bordet.be   
Principal Investigator: Marie MAEREVOET, MD         
Université Catholique de Louvain Saint Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Eric VAN DEN NESTE, MD       eric.vandenneste@uclouvain.be   
Principal Investigator: Eric VAN DEN NESTE, MD         
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Delphine PRANGER, MD       delphine.pranger@ghdc.be   
Principal Investigator: Delphine PRANGER, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Koenraad VAN EYGEN, MD       koen.vaneygen@azgroeninge.be   
Principal Investigator: Koenraad VAN EYGEN, MD         
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact: Christophe BONNET, MD       cbonnet@ulg.ac.be   
Principal Investigator: Christophe BONNET, MD         
CH de la Tourelle-Peltzer Recruiting
Verviers, Belgium, 4800
Contact: Gaëtan VANSTRAELEN, MD       gaetan.vanstraelen@chplt.be   
Principal Investigator: Gaëtan VANSTRAELEN, MD         
Université Catholique de Louvain Mont Godinne Recruiting
Yvoir, Belgium
Contact: Marc ANDRE, MD       marc.andre@uclouvain.be   
Principal Investigator: Marc ANDRE, MD         
France
CHU d'Amiens Recruiting
AMIENS Cedex 1, France, 80054
Contact: Jean Pierre MAROLLEAU       marolleau.jean-pierre@chu-amiens.fr   
Principal Investigator: Jean Pierre MAROLLEAU, Professor         
CHU d'Angers Recruiting
Angers, France, 49000
Contact: Marie-Pierre MOLES       mpmoles@chu-angers.fr   
Principal Investigator: Marie-Pierre MOLES, Doctor         
CH d Avignon - Hopital Henri Duffaut Recruiting
Avignon Cedex 9, France, 84902
Contact: Borhane SLAMA       Bslama@ch-avignon.fr   
Principal Investigator: Borhane SLAMA, doctor         
CH Côte Basque Recruiting
Bayonne, France, 64100
Contact: Anne BANOS       abanos@ch-cotebasque.fr   
Principal Investigator: Anne BANOS, doctor         
CHU Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Jean FONTAN       jfontan@chu-besancon.fr   
Principal Investigator: Jean FONTAN, MD         
CH de Blois Recruiting
Blois, France, 41000
Contact: Abderrazak EL YAMANI       elyamaa@ch-blois.fr   
Principal Investigator: Abderrazak EL YAMANI, Doctor         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Anna SCHMITT       a.schmitt@bordeaux.unicancer.fr   
Principal Investigator: Anna SCHMITT, MD         
Polyclinique Bordeaux Nord Recruiting
Bordeaux, France, 33300
Contact: Olivier FITOUSSI       o.fitoussi@bordeauxnord.com   
Principal Investigator: Olivier FITOUSSI, doctor         
CH du Dr Duchenne Recruiting
BOULOGNE SUR MER Cedex, France, 62321
Contact: Bachra CHOUFI       b.choufi@ch-boulogne.fr   
Principal Investigator: Bachra CHOUFI, doctor         
CHU Morvan Recruiting
Brest, France, 29609
Contact: Adrian TEMPESCUL       adrian.tempescul@chu-brest.fr   
Principal Investigator: Adrian TEMPESCUL, Doctor         
CHU Caen Recruiting
Caen, France, 14000
Contact: Christophe FRUCHART       fruchart-c@chu-caen.fr   
Principal Investigator: Christophe FRUCHART, Doctor         
MEDIPOLE de SAVOIE Recruiting
Challes les Eaux, France, 73190
Contact: Selim CORM       selim.corm@gmail.com   
Principal Investigator: Selim Corm         
CH Chambéry Recruiting
Chambery, France, 73011
Contact: Maya Hacini       maya.hacini@ch-metropole-savoie.fr   
Principal Investigator: Maya HACINI, Doctor         
Hopital Antoine Beclere Recruiting
Clamart, France, 92140
Contact: François BOUE       francois.boue@abc.aphp.fr   
Principal Investigator: François BOUE, Professor         
Pôle Santé République Recruiting
CLERMONT FERRAND Cedex 2, France, 63050
Contact: Joël FLEURY       jfleury@polesanterepublique.com   
Principal Investigator: Joël FLEURY, Doctor         
CHU Estaing Recruiting
Clermont Ferrand, France, 63000
Contact: Victoria CACHEUX       vcacheux@chu-clermontferrand.fr   
Principal Investigator: Victoria CACHEUX, Doctor         
CH Sud Francilien de Corbeil Recruiting
Corbeil Essonnes, France, 91108
Contact: Bertrand JOLY       bertrand.joly@ch-sud-francilien.fr   
Principal Investigator: Bertrand JOLY, Doctor         
Hopital Henri Mondor Recruiting
Creteil, France, 94010
Contact: Corinne HAIOUN       corinne.haioun@hmn.aphp.fr   
Principal Investigator: Corinne HAIOUN, Professor         
CHU Le Bocage Recruiting
Dijon, France, 21034
Contact: Olivier CASASNOVAS       olivier.casasnovas@chu-dijon.fr   
Principal Investigator: Olivier CASASNOVAS, Doctor         
CH Dunkerque Recruiting
Dunkerque, France, 59385
Contact: Jean Michel PIGNON       jean-michel.pignon@ch-dunkerque.fr   
Principal Investigator: Jean-Michel PIGNON, Doctor         
Institut Daniel Hollard Recruiting
GRENOBLE Cedex 1, France, 38028
Contact: Cécile LEYRONNAS       c.leyronnas@ghm-grenoble.fr   
Principal Investigator: Cécile LEYRONNAS, Doctor         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Rémy GRESSIN       rgressin@chu-grenoble.fr   
Principal Investigator: Rémy GRESSIN, Doctor         
CH Départemental Recruiting
La Roche Sur Yon, France, 85925
Contact: Hervé MAISONNEUVE       herve.maisonneuve@chd-vendee.fr   
Principal Investigator: Hervé MAISONNEUVE, Doctor         
Hôpital André Mignot Recruiting
Le Chesnay, France, 78157
Contact: Hassan FARHAT, MD       hfarhat@ch-versailles.fr   
Principal Investigator: Hassan FARHAT, MD         
CH du Mans Recruiting
Le Mans, France, 72000
Contact: Kamel LARIBI       klaribi@ch-lemans.fr   
Principal Investigator: Kamel LARIBI, Doctor         
Clinique Victor Hugo Recruiting
Le Mans, France, 72000
Contact: Katell LE DÛ       k.ledu@cjb72.org   
Principal Investigator: Katell LE DÛ, Doctor         
CH de Lens Recruiting
Lens, France, 62300
Contact: Daniela ROBU       drobu@ch-lens.fr   
Principal Investigator: Daniela ROBU, doctor         
CHU Claude Hurriez Recruiting
Lille, France, 59037
Contact: Franck MORSCHHAUSER       franck.morschhauser@chru-lille.fr   
Principal Investigator: Franck MORSCHHAUSER, Doctor         
Centre Leon Berard Recruiting
Lyon Cedex 8, France, 69373
Contact: Emmanuelle NICOLAS-VIRELIZIER       emmanuelle.nicolas@lyon.unicancer.fr   
Principal Investigator: Emmanuelle NICOLAS- VIRELIZIER, Doctor         
Institut Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Reda BOUABDALLAH       bouabdallahr@ipc.unicancer.fr   
Principal Investigator: Reda BOUABDALLAH, doctor         
CH de Meaux Recruiting
Meaux, France, 77104
Contact: Jamilé FRAYER       j-frayfer@ch-meaux.fr   
Principal Investigator: Jamilé FRAYFER, Doctor         
CH de la Région Annecy-Genevois Recruiting
Metz-Tessy, France, 74374
Contact: Nicolas DAGUINDAU       ndaguindau@ch-annecy.fr   
Principal Investigator: Nicolas DAGUINDAU, Doctor         
Hôpital Bon Secours Recruiting
Metz, France, 57038
Contact: Philippe CARASSOU       p.carassou@chr-metz-thionville.fr   
Principal Investigator: Philippe CARASSOU, Doctor         
CHU Montpellier Recruiting
MONTPELLIER Cedex 5, France, 34295
Contact: Guillaume CARTRON       g-cartron@chu-montpellier.fr   
Principal Investigator: Guillaume CARTRON, Professor         
CHU Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Steven LE GOUILL       steven.legouill@chu-nantes.fr   
Principal Investigator: Steven LE GOUILL, Professor         
CHR de la Source Recruiting
ORLEANS cedex 2, France, 45067
Contact: Omar BENBRAHIM         
Contact       omar.benbrahim@chr-orleans.fr   
Principal Investigator: Omar BENBRAHIM, Doctor         
Hôpital Saint Louis Recruiting
Paris cedex 10, France, 75475
Contact: Catherine THIEBLEMONT       catherine.thieblemont@sls.aphp.fr   
Principal Investigator: Catherine THIEBLEMONT, Professor         
Hopital Saint Antoine Recruiting
Paris, France, 75012
Contact: Zora MARJANOVIC       zora.marjanovic@sat.aphp.fr   
Principal Investigator: Zora MARJANOVIC, Doctor         
Hôpital de la Pitié Salpêtrière Recruiting
Paris, France, 75651
Contact: Jean GABARRE       jean.gabarre@psl.aphp.fr   
Principal Investigator: Jean GABARRE, doctor         
Hôpital Necker Recruiting
Paris, France, 75743
Contact: Richard DELARUE       richard.delarue@nck.aphp.fr   
Principal Investigator: Richard DELARUE, doctor         
CH Perpignan Recruiting
Perpignan, France, 66046
Contact: Laurence SAHNES       laurence.sanhes@ch-perpignan.fr   
Principal Investigator: Laurence SANHES, Doctor         
Hôpital Haut Lévêque Recruiting
Pessac, France, 33604
Contact: Krimo BOUABDALLAH       krimo.bouabdallah@chu-bordeaux.fr   
Principal Investigator: Krimo BOUABDALLAH, Doctor         
CHU Lyon Sud Recruiting
Pierre Bénite cedex, France, 69495
Contact: Gilles SALLES       gilles.salles@chu-lyon.fr   
Principal Investigator: Gilles SALLES, Professor         
CHU Robert Debre Recruiting
Reims, France, 51092
Contact: Alain DELMER       adelmer@chu-reims.fr   
Principal Investigator: Alain DELMER, Doctor         
CHU Pontchaillou Recruiting
Rennes, France, 35033
Contact: Thierry LAMY de la CHAPELLE       thierry.lamy.de.la.chapelle@chu-rennes.fr   
Principal Investigator: Thierry LAMY de la CHAPELLE, Professor         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Hervé TILLY       herve.tilly@chb.unicancer.fr   
Principal Investigator: Hervé TILLY, Professor         
CH Saint Quentin Recruiting
Saint Quentin, France, 02321
Contact: Réda GARIDI       r.garidi@ch-stquentin.fr   
Principal Investigator: Réda GARIDI, Doctor         
Institut de cancérologie de la Loire Recruiting
St priest en jarez, France, 42271
Contact: Christiane MOUNIER       christiane.mounier@icloire.fr   
Principal Investigator: Christiane MOUNIER, Professor         
CHU de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Luc Matthieu FORNECKER       luc-matthieu.fornecker@chru-strasbourg.fr   
Principal Investigator: Luc-Matthieu FORNECKER, Doctor         
CHU Purpan Recruiting
Toulouse, France, 31059
Contact: Lucie OBERIC       oberic.l@chu-toulouse.fr   
Principal Investigator: Lucie OBERIC         
CHU Bretonneau Recruiting
Tours, France, 37044
Contact: Caroline DARTIGEAS       c.dartigeas@chu-tours.fr   
Principal Investigator: Caroline DARTIGEAS, doctor         
CHU Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: PIERRE FEUGIER       p.feugier@chu-nancy.fr   
Principal Investigator: Pierre FEUGIER, Professor         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Vincent RIBRAG       vincent.ribrag@gustaveroussy.fr   
Principal Investigator: Vincent RIBRAG, doctor         
Germany
Gesundheitszentrum St. Marien GmbH Recruiting
Amberg, Germany, 92224
Contact: Ludwig Fischer v. Weikersthal, MD       weikersthal.ludwig@gesundheitszentrum.klinikum-amberg.de   
Principal Investigator: Ludwig Fischer v. Weikersthal, MD         
Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Antonio Pezzutto, Prof.         
Principal Investigator: Antonio Pezzutto, Prof.         
Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Andreas Loew, MD       andreas.loew@charite.de   
Principal Investigator: Andreas Loew, MD         
Städt. Klinikum Braunschweig gGmbH Recruiting
Braunschweig, Germany, 38114
Contact: Jürgen Krauter, Prof.       medklinik3@klinikum-braunschweig.de   
Principal Investigator: Jürgen Krauter, Prof.         
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH Recruiting
Bremen, Germany, 28239
Contact: Ralf Trappe, MD       r.trappe@@diako-bremen.de   
Principal Investigator: Ralf Trappe, MD         
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 9116
Contact: Mathias Hänel, MD       m.haenel@skc.de   
Principal Investigator: Mathias Hänel, MD         
Marien Hospital Düsseldorf Recruiting
Düsseldorf, Germany, 40479
Contact: Aristoteles GIAGOUNIDIS, MD         
Principal Investigator: Aristoteles GIAGOUNIDIS, MD         
St. Antonius Hospital Recruiting
Eschweiler, Germany, 52249
Contact: Peter Staib, MD       peter.staib@sah-eschweiler.de   
Principal Investigator: Peter Staib, MD         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Jan Dürig, Prof.       jan.duerig@uk-essen.de   
Principal Investigator: Jan Dürig, Prof.         
Klinikum Frankfurt GmbH Recruiting
Frankfurt (Oder), Germany
Contact: Arkadius Gawliczek, MD         
Principal Investigator: Arkadius Gawliczek, MD         
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Christian Andreas Schmidt, Prof.       christian.schmidt@uni-greifswald.de   
Principal Investigator: Christian Andreas Schmidt, Prof.         
Kath. Krankenhaus Hagen gem. GmbH Recruiting
Hagen, Germany, 58095
Contact: Hans-Walter Lindemann, MD       w.lindemann@kkh-hagen.de   
Principal Investigator: Hans-Walter Lindemann, MD         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Judith Dierlamm, Prof.       dierlamm@uke.de   
Principal Investigator: Judith Dierlamm, Prof.         
Klinikum Herford Recruiting
Herford, Germany, 32049
Contact: Stephan Bildat, MD       stephan.bildat@klinikum-herford.de   
Principal Investigator: Stephan Bildat, MD         
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Contact: Michael Pfreundschuh, Prof       Michael.Pfreundschuh @uks.eu   
Principal Investigator: Michael Pfreundschuh, Prof         
Städt. Klinikum Karlsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: Martin Bentz, Prof.       martin.bentz@klinikum-karlsruhe.de   
Principal Investigator: Martin Bentz, Prof.         
Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel Recruiting
Kiel, Germany, 24116
Contact: Christiane Pott, MD       c.pott@med2.uni-kiel.de   
Principal Investigator: Christiane Pott, MD         
Internistische Praxis /Hämatologie und Onkologie Recruiting
Kronach, Germany, 96317
Contact: Martina Stauch, MD       drm@drstauch.de   
Principal Investigator: Martina Stauch, MD         
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Contact: Kai Hübel, Prof.       kai.huebel@uk-koeln.de   
Principal Investigator: Kai Hübel, Prof.         
Onkologisches Zentrum - Lebach Recruiting
Lebach, Germany, 66822
Contact: Stephan Kremers, MD       stephankremers@onkologie-lebach.de   
Principal Investigator: Stephan Kremers, MD         
Klinikum Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Contact: Martin Hoffmann, MD       hoffmanm@klilu.de   
Principal Investigator: Martin Hoffmann, MD         
Stauferklinikum Schwäbisch Gmünd Recruiting
Mutlangen, Germany, 73557
Contact: Holger Hebart, Prof.       holger.hebart@stauferklinikum.de   
Principal Investigator: Holger Hebart, Prof.         
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus) Recruiting
Mönchengladbach, Germany, 41063
Contact: Ullrich Graeven, Prof.       ullrich.graeven@mariahilf.de   
Principal Investigator: Ullrich Graeven, Prof.         
Klinikum rechts der Isar der TU München Recruiting
München, Germany, 81675
Contact: Ulrich Keller, Prof.       ulrich.keller@mri.tum.de   
Principal Investigator: Ulrich Keller, Prof.         
Klinikum der Universität München Recruiting
München, Germany, 83177
Contact: Martin Dreyling, Prof.       martin.dreyling@med.uni-muenchen.de   
Principal Investigator: Martin Dreyling, Prof.         
Gemeinschaftspraxis für Hämatologie und Onkologie Recruiting
Münster, Germany, 48149
Contact: Rüdiger Liersch, MD       liersch@onkologie-muenster.de   
Principal Investigator: Rüdiger Liersch, MD         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Georg Lenz, Prof       georg.lenz@ukmuenster.de   
Principal Investigator: Georg Lenz, Prof         
Gemeinschaftspraxis für Hämatologie und internistische Onkologie Recruiting
Neumarkt, Germany, 92318
Contact: Ekkehart Ladda, MD       eladda@onkologie-neumarkt.de   
Principal Investigator: Ekkehart Ladda, MD         
Klinikum Nürnberg Recruiting
Nürnberg, Germany, 90419
Contact: Josef Birkmann, MD       josef.birkmann@klinikum-nuernberg.de   
Principal Investigator: Josef Birkmann, MD         
Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie Recruiting
Offenbach, Germany, 63065
Contact: Hans-Peter Böck, MD       boeck@onkologie-offenbach.de   
Principal Investigator: Hans-Peter Böck, MD         
Brüderkrankenhaus St. Josef Paderborn Recruiting
Paderborn, Germany, 33098
Contact: Tobias Gaska, MD       t.gaska@bk-paderborn.de   
Principal Investigator: Tobias Gaska, MD         
Universitätsklinik Rostock Recruiting
Rostock, Germany, 18057
Contact: Christina Große-Thie, MD       christina.grosse-thie@med.uni-rostock.de   
Principal Investigator: Christina Große-Thie, MD         
Mutterhaus der Borromäerinnen GmbH Recruiting
Trier, Germany, 54219
Contact: Rolf Mahlberg, MD       mahlberg@mutterhaus.de   
Principal Investigator: Rolf Mahlberg, MD         
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Martin Sökler       martin.soekler@med.uni-tuebingen.de   
Principal Investigator: Martin Sökler         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Stephan Stilgenbauer, Prof.       stephan.stilgenbauer@uniklinik-ulm.de   
Principal Investigator: Stephan Stilgenbauer, Prof.         
Netherlands
MC Alkmaar Recruiting
Alkmaar, Netherlands, 1800AM
Contact: Hein Visser       h.visser@nwz.nl   
Principal Investigator: Hein Visser         
VUMC Recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Josée Zijlstra-Baalbergen, MD       j.zijlstra@vumc.nl   
Principal Investigator: Josée Zijlstra-Baalbergen, MD         
OLVG Recruiting
Amsterdam, Netherlands, 1090 HM
Contact: W Terpstra         
Principal Investigator: W Terpstra         
AMC Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: Marie José KERSTEN       m.j.kersten@amc.uva.nl   
Principal Investigator: Marie José KERSTEN         
Amphia ziekenhuis, locatie Langendijk Recruiting
Breda, Netherlands, 4800 RL
Contact: Joost VAN ESSER       esserj@amphia.nl   
Principal Investigator: Joost VAN ESSER         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands, 2600 GA
Contact: Rolf BROUWER       brouwer@rdgg.nl   
Principal Investigator: Rolf BROUWER         
Jeroen Bosch ziekenhuis Recruiting
Den Bosch, Netherlands, 5200 ME
Contact: Hans PRUIJT       h.pruijt@jbz.nl   
Principal Investigator: Hans PRUIJT         
Hagaziekenhuis, locatie Leyweg Recruiting
Den Haag, Netherlands, 2504 LN
Contact: Lara BOHMER       l.h.bohmer@hagaziekenhuis.nl   
Principal Investigator: Lara BOHMER         
Gemini Ziekenhuis Recruiting
Den Helder, Netherlands, 1780 AT
Contact: Arie VAN DER SPEK       A.C.vanderSpek@gemini-ziekenhuis.nl   
Principal Investigator: Arie VAN DER SPEK         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7500 KA
Contact: Tjeerd SNIJDERS       sigo@mst.nl   
Principal Investigator: Tjeerd SNIJDERS         
Zuyderland MC Recruiting
Geleen, Netherlands, 6130 MB
Contact: Roel VAN KAMPEN       r.vankampen@orbisconcern.nl   
Principal Investigator: Roel VAN KAMPEN         
Admiraal De Ruyter Ziekenhuis, Goes Recruiting
Goes, Netherlands, 4460 BB
Contact: Yavuz BILGIN       y.bilgin@adrz.nl   
Principal Investigator: Yavuz BILGIN         
Groene Hart Ziekenhuis Recruiting
Gouda, Netherlands, 2800 BB
Contact: Bea TANIS       bea.tanis@ghz.nl   
Principal Investigator: Bea TANIS         
UMCG Recruiting
Groningen, Netherlands, 9700 RB
Contact: Marcel Nijland       m.nijland@umcg.nl   
Principal Investigator: Marcel Nijland         
Spaarne ziekenhuis Recruiting
Hoofddorp, Netherlands, 2130 AT
Contact: Aart BEEKER       abeeker@spaarneziekenhuis.nl   
Principal Investigator: Aart BEEKER         
MC Leeuwarden Zuid Recruiting
Leeuwarden, Netherlands, 8901 BR
Contact: Mels HOOGENDOORN       m.hoogendoorn@znb.nl   
Principal Investigator: Mels HOOGENDOORN         
Maastricht UMC Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Harry SCHOUTEN       harry.schouten@mumc.nl   
Principal Investigator: Harry SCHOUTEN         
Sint Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3430 EM
Contact: Josephine VOS       jm.vos@antoniusziekenhuis.nl   
Principal Investigator: Josephine VOS         
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Wendy Stevens       W.Stevens@hemat.umcn.nl   
Principal Investigator: Wendy Stevens         
Bravis ziekenhuis Recruiting
Roosendaal, Netherlands, 4700 AZ
Contact: Nicole VAN DEN BURG-DE GRAAUW       n.degraauw@bravis.nl   
Principal Investigator: Nicole VAN DEN BURG-DE GRAAUW         
Erasmus MC - Centrum Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Elly LUGTENBURG       p.lugtenburg@erasmusmc.nl   
Principal Investigator: Elly LUGTENBURG         
Erasmus MC - Daniel Recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Jeanette Doorduijn       j.doorduijn@erasmusmc.nl   
Principal Investigator: Jeanette Doorduijn         
Maasstadziekenhuis Recruiting
Rotterdam, Netherlands, 3079 DZ
Contact: Rineke Leys         
Principal Investigator: Rineke Leys         
St.Elisabeth ZH Recruiting
Tilburg, Netherlands, 5000 LC
Contact: Marc DURIAN       m.durian@etz.nl   
Principal Investigator: Marc DURIAN         
Isala Klinieken, Sophia Recruiting
Zwolle, Netherlands, 8000 GK
Contact: Marinus VAN MARWIJK KOOY       m.van.marwijk@isala.nl   
Principal Investigator: Marinus VAN MARWIJK KOOY         
Poland
Gdansk University School of Medicine Not yet recruiting
Gdańsk, Poland, 80-211
Contact: Michal Taszner         
Principal Investigator: Michal Taszner         
Szpitale Wojewódzkie Not yet recruiting
Gdynia, Poland, 81-519
Contact: Jan Maciej Zaucha         
Principal Investigator: Jan Maciej Zaucha         
University Hospital Not yet recruiting
Kraków, Poland, 31-501
Contact: Wojciech Jurczak         
Principal Investigator: Wojciech SJurczak         
Warminsko-Mazurskie Centrum Onkologii Not yet recruiting
Olsztyn, Poland, 10-228
Contact: Wanda Knopinska-Posluszny       wanda.knopinska@gmail.com   
Principal Investigator: Wanda Knopinska-Posluszny         
Institute of Hematology and Transfusiology Not yet recruiting
Warszawa, Poland, 02-776
Contact: Ewa Lech-Marańda       ewamaranda@wp.pl   
Principal Investigator: Ewa Lech-Marańda         
MSCM Institute and Oncology Centre Not yet recruiting
Warszawa, Poland, 02-781
Contact: Jan Walewski       walewski@coi.waw.pl   
Principal Investigator: Jan Walewski         
Portugal
Instituto Português de Oncologia de Lisboa de Francisco Gentil Recruiting
Lisboa, Portugal, 1099-023
Contact: Maria GOMES DA SILVA, MD       mgsilva@ipolisboa.min-saude.pt   
Principal Investigator: Maria GOMES DA SILVA, MD         
Spain
Hospital Universitario Fundación Alcorcón Recruiting
Alcorcón, Spain, 28922
Contact: Javier Peñalver       fjpenalver@fhalcorcon.es   
Principal Investigator: Javier Peñalver         
Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol Recruiting
Badalona, Spain, 8916
Contact: Juan Manuel Sancho       jsancho@iconcologia.net   
Principal Investigator: Juan Manuel Sancho         
Hospital Universitario Vall d'hebron Recruiting
Barcelona, Spain, 8035
Contact: Ana Marin-Niebla       ana.marin@vhebron.net   
Principal Investigator: Ana Marin-Niebla         
Hospital Clínic Recruiting
Barcelona, Spain, 8036
Contact: Eva Giné Soca       egine@clinic.cat   
Principal Investigator: Eva Giné Soca         
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain, 10003
Contact: Fernando Carnicero       fcarnicero@gmail.com   
Principal Investigator: Fernando Carnicero         
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Javier López       jlopezj.hrc@salud.madrid.org   
Principal Investigator: Javier López         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Carlos Grande       cgrandegar@yahoo.es   
Principal Investigator: Carlos Grande         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: Concha Nicolás       conchanicolas61@gmail.com   
Principal Investigator: Concha Nicolás         
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Carlos Panizo       cpanzio@unav.es   
Principal Investigator: Carlos Panizo         
Hospital Clínico de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Alejandro Martin         
Principal Investigator: Alejandro Martin         
Hospital Clinico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Maria José Terol         
Principal Investigator: Maria José Terol         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Layout table for investigator information
Principal Investigator: Martin Dreyling, Prof. Dr. MCL Network
Principal Investigator: Vincent Ribrag, Dr Lymphoma Study Association
Principal Investigator: Johanna Cornelia Kluin-Nelemans, Prof. Dr. MCL Network

Layout table for additonal information
Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01865110     History of Changes
Other Study ID Numbers: MCL R2 Elderly
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by The Lymphoma Academic Research Organisation:
Mantle Cell Lymphoma
RCHOP
RHAD
rituximab
lenalidomide
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Rituximab
Lenalidomide
Cyclophosphamide
Vincristine
Doxorubicin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Anti-Inflammatory Agents