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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01865110
Recruitment Status : Recruiting
First Posted : May 30, 2013
Last Update Posted : March 13, 2019
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

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

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 identifier (NCT number): NCT01865110

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Contact: Christine STEPHAN +33 4 72 66 93 33

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ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Pierre ZACHEE, MD   
Principal Investigator: Pierre ZACHEE, MD         
A. Z. Sint-Jan Recruiting
Bruges, Belgium, 8000
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Principal Investigator: Sylvia SNAUWAERT, MD         
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
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Principal Investigator: Marie MAEREVOET, MD         
Université Catholique de Louvain Saint Luc Recruiting
Bruxelles, Belgium, 1200
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Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
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Principal Investigator: Delphine PRANGER, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
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Liège, Belgium, 4000
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Principal Investigator: Christophe BONNET, MD         
CH de la Tourelle-Peltzer Recruiting
Verviers, Belgium, 4800
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Principal Investigator: Gaëtan VANSTRAELEN, MD         
Université Catholique de Louvain Mont Godinne Recruiting
Yvoir, Belgium
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Principal Investigator: Marc ANDRE, MD         
CHU d'Amiens Recruiting
AMIENS Cedex 1, France, 80054
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Angers, France, 49000
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Avignon Cedex 9, France, 84902
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Bayonne, France, 64100
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Besancon, France, 25030
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Blois, France, 41000
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Bordeaux, France, 33076
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Bordeaux, France, 33300
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Brest, France, 29609
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Caen, France, 14000
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Challes les Eaux, France, 73190
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Chambery, France, 73011
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Clamart, France, 92140
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CLERMONT FERRAND Cedex 2, France, 63050
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Corbeil Essonnes, France, 91108
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Creteil, France, 94010
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Dijon, France, 21034
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Le Mans, France, 72000
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Lens, France, 62300
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Lille, France, 59037
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Meaux, France, 77104
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Metz-Tessy, France, 74374
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Metz, France, 57038
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MONTPELLIER Cedex 5, France, 34295
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Nantes, France, 44093
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ORLEANS cedex 2, France, 45067
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Paris cedex 10, France, 75475
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Pessac, France, 33604
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Reims, France, 51092
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Rennes, France, 35033
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Rouen, France, 76038
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Saint Quentin, France, 02321
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Institut de cancérologie de la Loire Recruiting
St priest en jarez, France, 42271
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CHU de Strasbourg Recruiting
Strasbourg, France, 67098
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Toulouse, France, 31059
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Tours, France, 37044
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Vandoeuvre Les Nancy, France, 54511
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Institut Gustave Roussy Recruiting
Villejuif, France, 94805
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Gesundheitszentrum St. Marien GmbH Recruiting
Amberg, Germany, 92224
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Principal Investigator: Ludwig Fischer v. Weikersthal, MD         
Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
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Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
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Principal Investigator: Andreas Loew, MD         
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Braunschweig, Germany, 38114
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Bremen, Germany, 28239
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Chemnitz, Germany, 9116
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Marien Hospital Düsseldorf Recruiting
Düsseldorf, Germany, 40479
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St. Antonius Hospital Recruiting
Eschweiler, Germany, 52249
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Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
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Klinikum Frankfurt GmbH Recruiting
Frankfurt (Oder), Germany
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Universitätsmedizin Greifswald Recruiting
Greifswald, Germany, 17475
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Kath. Krankenhaus Hagen gem. GmbH Recruiting
Hagen, Germany, 58095
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Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
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Principal Investigator: Judith Dierlamm, Prof.         
Klinikum Herford Recruiting
Herford, Germany, 32049
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Homburg/Saar, Germany, 66421
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Karlsruhe, Germany, 76133
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Kiel, Germany, 24116
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Internistische Praxis /Hämatologie und Onkologie Recruiting
Kronach, Germany, 96317
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Köln, Germany, 50937
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Onkologisches Zentrum - Lebach Recruiting
Lebach, Germany, 66822
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Principal Investigator: Stephan Kremers, MD         
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Ludwigshafen, Germany, 67063
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Mutlangen, Germany, 73557
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Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus) Recruiting
Mönchengladbach, Germany, 41063
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Principal Investigator: Ullrich Graeven, Prof.         
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München, Germany, 81675
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Principal Investigator: Ulrich Keller, Prof.         
Klinikum der Universität München Recruiting
München, Germany, 83177
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Principal Investigator: Martin Dreyling, Prof.         
Gemeinschaftspraxis für Hämatologie und Onkologie Recruiting
Münster, Germany, 48149
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Principal Investigator: Rüdiger Liersch, MD         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
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Principal Investigator: Georg Lenz, Prof         
Gemeinschaftspraxis für Hämatologie und internistische Onkologie Recruiting
Neumarkt, Germany, 92318
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Principal Investigator: Ekkehart Ladda, MD         
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Nürnberg, Germany, 90419
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Principal Investigator: Josef Birkmann, MD         
Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie Recruiting
Offenbach, Germany, 63065
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Paderborn, Germany, 33098
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Rostock, Germany, 18057
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Mutterhaus der Borromäerinnen GmbH Recruiting
Trier, Germany, 54219
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Principal Investigator: Rolf Mahlberg, MD         
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
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Ulm, Germany, 89081
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MC Alkmaar Recruiting
Alkmaar, Netherlands, 1800AM
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Amsterdam, Netherlands, 1007 MB
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Amsterdam, Netherlands, 1090 HM
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Amsterdam, Netherlands, 1100 DD
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Breda, Netherlands, 4800 RL
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Delft, Netherlands, 2600 GA
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Den Bosch, Netherlands, 5200 ME
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Den Haag, Netherlands, 2504 LN
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Den Helder, Netherlands, 1780 AT
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Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7500 KA
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Geleen, Netherlands, 6130 MB
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Goes, Netherlands, 4460 BB
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Gouda, Netherlands, 2800 BB
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Groningen, Netherlands, 9700 RB
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Maastricht, Netherlands, 6202 AZ
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Principal Investigator: Harry SCHOUTEN         
Sint Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3430 EM
Contact: Josephine VOS   
Principal Investigator: Josephine VOS         
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Wendy Stevens   
Principal Investigator: Wendy Stevens         
Bravis ziekenhuis Recruiting
Roosendaal, Netherlands, 4700 AZ
Contact: Nicole VAN DEN BURG-DE GRAAUW   
Principal Investigator: Nicole VAN DEN BURG-DE GRAAUW         
Erasmus MC - Centrum Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Elly LUGTENBURG   
Principal Investigator: Elly LUGTENBURG         
Erasmus MC - Daniel Recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Jeanette Doorduijn   
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   
Principal Investigator: Marc DURIAN         
Isala Klinieken, Sophia Recruiting
Zwolle, Netherlands, 8000 GK
Contact: Marinus VAN MARWIJK KOOY   
Principal Investigator: Marinus VAN MARWIJK KOOY         
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   
Principal Investigator: Wanda Knopinska-Posluszny         
Institute of Hematology and Transfusiology Not yet recruiting
Warszawa, Poland, 02-776
Contact: Ewa Lech-Marańda   
Principal Investigator: Ewa Lech-Marańda         
MSCM Institute and Oncology Centre Not yet recruiting
Warszawa, Poland, 02-781
Contact: Jan Walewski   
Principal Investigator: Jan Walewski         
Instituto Português de Oncologia de Lisboa de Francisco Gentil Recruiting
Lisboa, Portugal, 1099-023
Contact: Maria GOMES DA SILVA, MD   
Principal Investigator: Maria GOMES DA SILVA, MD         
Hospital Universitario Fundación Alcorcón Recruiting
Alcorcón, Spain, 28922
Contact: Javier Peñalver   
Principal Investigator: Javier Peñalver         
Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol Recruiting
Badalona, Spain, 8916
Contact: Juan Manuel Sancho   
Principal Investigator: Juan Manuel Sancho         
Hospital Universitario Vall d'hebron Recruiting
Barcelona, Spain, 8035
Contact: Ana Marin-Niebla   
Principal Investigator: Ana Marin-Niebla         
Hospital Clínic Recruiting
Barcelona, Spain, 8036
Contact: Eva Giné Soca   
Principal Investigator: Eva Giné Soca         
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain, 10003
Contact: Fernando Carnicero   
Principal Investigator: Fernando Carnicero         
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Javier López   
Principal Investigator: Javier López         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Carlos Grande   
Principal Investigator: Carlos Grande         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: Concha Nicolás   
Principal Investigator: Concha Nicolás         
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Carlos Panizo   
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
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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

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Responsible Party: The Lymphoma Academic Research Organisation 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
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
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