R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL
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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. |
| ClinicalTrials.gov Identifier: NCT01865110 |
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Recruitment Status :
Recruiting
First Posted : May 30, 2013
Last Update Posted : March 13, 2019
|
Sponsor:
The Lymphoma Academic Research Organisation
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
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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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
|
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Active Comparator: Standart induction arm
8 cycles of R-CHOP administered in 3 week cycles
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Drug: R-CHOP
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
Other Name: rituximab, CHOP |
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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
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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 |
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Active Comparator: Maintenance standart arm
13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
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Drug: Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Other Name: Mabthera |
Primary Outcome Measures :
- 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.
| 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
| Contact: Christine STEPHAN | +33 4 72 66 93 33 | christine.stephan@lysarc.org |
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Locations
| 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
| 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 |
| 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:
|
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 |