R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL
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
1 other identifier
interventional
623
7 countries
143
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2013
Longer than P75 for phase_3
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedMarch 5, 2025
March 1, 2025
7.1 years
May 24, 2013
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
2.5 years after last patient randomized in maintenance
2.5 years
Study Arms (4)
Induction experimental arm
EXPERIMENTALR-CHOP / R-HAD : Alternating 3 cycles of R-CHOP administered in 3 week cycles + 3 cycles of R-HAD administered in 4 week cycles.
Standart induction arm
ACTIVE COMPARATOR8 cycles of R-CHOP administered in 3 week cycles
Maintenance experimental arm
EXPERIMENTALlenalidomide + 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
Maintenance standart arm
ACTIVE COMPARATOR13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
Interventions
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
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
Rituximab SC 1400 mg every 8 weeks for 24 months
Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (143)
ZNA Stuivenberg
Antwerp, 2060, Belgium
A. Z. Sint-Jan
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Université Catholique de Louvain Saint Luc
Brussels, 1200, Belgium
Grand Hopital de Charleroi
Charleroi, 6000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU de Liège
Liège, 4000, Belgium
CH de la Tourelle-Peltzer
Verviers, 4800, Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, Belgium
CHU d'Amiens
Amiens, 80054, France
CHU d'Angers
Angers, 49000, France
CH d Avignon - Hopital Henri Duffaut
Avignon, 84902, France
CH Côte Basque
Bayonne, 64100, France
CHU Jean Minjoz
Besançon, 25030, France
CH de Blois
Blois, 41000, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord
Bordeaux, 33300, France
CH du Dr Duchenne
Boulogne-sur-Mer, 62321, France
CHU Morvan
Brest, 29609, France
CHU Caen
Caen, 14000, France
MEDIPOLE de SAVOIE
Challes-les-Eaux, 73190, France
CH Chambéry
Chambéry, 73011, France
CHU de Châlon-sur-Sâone - William Morey
Châlon-sur-Sâone, 71000, France
Hopital Antoine Beclere
Clamart, 92140, France
CHU Estaing
Clermont-Ferrand, 63000, France
Pôle Santé République
Clermont-Ferrand, 63050, France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, 91108, France
Hopital Henri Mondor
Créteil, 94010, France
CHU Le Bocage
Dijon, 21034, France
CH Dunkerque
Dunkirk, 59385, France
Institut Daniel Hollard
Grenoble, 38028, France
CHU de Grenoble
Grenoble, 38043, France
CH Départemental
La Roche-sur-Yon, 85925, France
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle, 17019, France
Hôpital André Mignot
Le Chesnay, 78157, France
CH du Mans
Le Mans, 72000, France
Clinique Victor Hugo
Le Mans, 72000, France
CH de Lens
Lens, 62300, France
CHU Claude Hurriez
Lille, 59037, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmette
Marseille, 13273, France
CH de Meaux
Meaux, 77104, France
Hôpital Bon Secours
Metz, 57038, France
CH de la Région Annecy-Genevois
Metz-Tessy, 74374, France
CHU Montpellier
Montpellier, 34295, France
CHU Hôtel Dieu
Nantes, 44093, France
CHR de la Source
Orléans, 45067, France
Hopital Saint Antoine
Paris, 75012, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital de la Pitié Salpêtrière
Paris, 75651, France
Hôpital Necker
Paris, 75743, France
CH Perpignan
Perpignan, 66046, France
Hôpital Haut Lévêque
Pessac, 33604, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
CH de Quimper Cornouaille
Quimper, 29107, France
CHU Robert Debre
Reims, 51092, France
CHU Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Institut de cancérologie de la Loire
Saint-Priest-en-Jarez, 42271, France
CH Saint Quentin
Saint-Quentin, 02321, France
CHU de Strasbourg
Strasbourg, 67098, France
CHU Purpan
Toulouse, 31059, France
CHU Bretonneau
Tours, 37044, France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
Gesundheitszentrum St. Marien GmbH
Amberg, 92224, Germany
Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, 12200, Germany
Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, 13353, Germany
Städt. Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Bremen, 28239, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 9116, Germany
Universitätsklinikum Köln
Cologne, 50937, Germany
Marien Hospital Düsseldorf
Düsseldorf, 40479, Germany
St. Antonius Hospital
Eschweiler, 52249, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum Frankfurt GmbH
Frankfurt (Oder), Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Kath. Krankenhaus Hagen gem. GmbH
Hagen, 58095, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Klinikum Herford
Herford, 32049, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421, Germany
Städt. Klinikum Karlsruhe
Karlsruhe, 76133, Germany
Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel
Kiel, 24116, Germany
Internistische Praxis /Hämatologie und Onkologie
Kronach, 96317, Germany
Onkologisches Zentrum - Lebach
Lebach, 66822, Germany
Klinikum Ludwigshafen
Ludwigshafen, 67063, Germany
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)
Mönchengladbach, 41063, Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557, Germany
Klinikum rechts der Isar der TU München
München, 81675, Germany
Klinikum der Universität München
München, 83177, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48149, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Gemeinschaftspraxis für Hämatologie und internistische Onkologie
Neumarkt, 92318, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie
Offenbach, 63065, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, 33098, Germany
Universitätsklinik Rostock
Rostock, 18057, Germany
Mutterhaus der Borromäerinnen GmbH
Trier, 54219, Germany
University Hospital Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Jeroen Bosch ziekenhuis
's-Hertogenbosch, 5200 ME, Netherlands
MC Alkmaar
Alkmaar, 1800AM, Netherlands
VUMC
Amsterdam, 1007 MB, Netherlands
OLVG
Amsterdam, 1090 HM, Netherlands
AMC
Amsterdam, 1100 DD, Netherlands
Amphia ziekenhuis, locatie Langendijk
Breda, 4800 RL, Netherlands
Reinier de Graaf Gasthuis
Delft, 2600 GA, Netherlands
Gemini Ziekenhuis
Den Helder, 1780 AT, Netherlands
Medisch Spectrum Twente
Enschede, 7500 KA, Netherlands
Zuyderland MC
Geleen, 6130 MB, Netherlands
Admiraal De Ruyter Ziekenhuis, Goes
Goes, 4460 BB, Netherlands
Groene Hart Ziekenhuis
Gouda, 2800 BB, Netherlands
UMCG
Groningen, 9700 RB, Netherlands
Spaarne ziekenhuis
Hoofddorp, 2130 AT, Netherlands
MC Leeuwarden Zuid
Leeuwarden, 8901 BR, Netherlands
Maastricht UMC
Maastricht, 6202 AZ, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, 3430 EM, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Bravis ziekenhuis
Roosendaal, 4700 AZ, Netherlands
Erasmus MC - Centrum
Rotterdam, 3000 CA, Netherlands
Erasmus MC - Daniel
Rotterdam, 3008 AE, Netherlands
Maasstadziekenhuis
Rotterdam, 3079 DZ, Netherlands
Hagaziekenhuis, locatie Leyweg
The Hague, 2504 LN, Netherlands
St.Elisabeth ZH
Tilburg, 5000 LC, Netherlands
Isala Klinieken, Sophia
Zwolle, 8000 GK, Netherlands
Gdansk University School of Medicine
Gdansk, 80-211, Poland
Szpitale Wojewódzkie
Gdynia, 81-519, Poland
University Hospital
Krakow, 31-501, Poland
Warminsko-Mazurskie Centrum Onkologii
Olsztyn, 10-228, Poland
Institute of Hematology and Transfusiology
Warsaw, 02-776, Poland
MSCM Institute and Oncology Centre
Warsaw, 02-781, Poland
Instituto Português de Oncologia de Lisboa de Francisco Gentil
Lisbon, 1099-023, Portugal
Hospital Universitario Fundación Alcorcón
Alcorcón, 28922, Spain
Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol
Badalona, 8916, Spain
Hospital Universitario Vall d'hebron
Barcelona, 8035, Spain
Hospital Clínic
Barcelona, 8036, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Clínico de Salamanca
Salamanca, 37007, Spain
Hospital Clinico de Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2013
First Posted
May 30, 2013
Study Start
November 1, 2013
Primary Completion
November 30, 2020
Study Completion
January 31, 2025
Last Updated
March 5, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share