R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL
NCT ID: NCT01865110
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2013-11-30
2025-01-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Standart induction arm
8 cycles of R-CHOP administered in 3 week cycles
R-CHOP
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
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
Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Lenalidomide
Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
Maintenance standart arm
13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Interventions
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R-CHOP
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
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
Rituximab
Rituximab SC 1400 mg every 8 weeks for 24 months
Lenalidomide
Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
≥ 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
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
60 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Martin Dreyling, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
MCL Network
Vincent Ribrag, Dr
Role: PRINCIPAL_INVESTIGATOR
Lymphoma Study Association
Johanna Cornelia Kluin-Nelemans, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
MCL Network
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
A. Z. Sint-Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Université Catholique de Louvain Saint Luc
Brussels, , Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU de Liège
Liège, , Belgium
CH de la Tourelle-Peltzer
Verviers, , Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, , Belgium
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CH d Avignon - Hopital Henri Duffaut
Avignon, , France
CH Côte Basque
Bayonne, , France
CHU Jean Minjoz
Besançon, , France
CH de Blois
Blois, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
CH du Dr Duchenne
Boulogne-sur-Mer, , France
CHU Morvan
Brest, , France
CHU Caen
Caen, , France
MEDIPOLE de SAVOIE
Challes-les-Eaux, , France
CH Chambéry
Chambéry, , France
CHU de Châlon-sur-Sâone - William Morey
Châlon-sur-Sâone, , France
Hopital Antoine Beclere
Clamart, , France
CHU Estaing
Clermont-Ferrand, , France
Pôle Santé République
Clermont-Ferrand, , France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, , France
Hopital Henri Mondor
Créteil, , France
CHU Le Bocage
Dijon, , France
CH Dunkerque
Dunkirk, , France
Institut Daniel Hollard
Grenoble, , France
CHU de Grenoble
Grenoble, , France
CH Départemental
La Roche-sur-Yon, , France
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle, , France
Hôpital André Mignot
Le Chesnay, , France
CH du Mans
Le Mans, , France
Clinique Victor Hugo
Le Mans, , France
CH de Lens
Lens, , France
CHU Claude Hurriez
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmette
Marseille, , France
CH de Meaux
Meaux, , France
Hôpital Bon Secours
Metz, , France
CH de la Région Annecy-Genevois
Metz-Tessy, , France
CHU Montpellier
Montpellier, , France
CHU Hôtel Dieu
Nantes, , France
CHR de la Source
Orléans, , France
Hopital Saint Antoine
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital de la Pitié Salpêtrière
Paris, , France
Hôpital Necker
Paris, , France
CH Perpignan
Perpignan, , France
Hôpital Haut Lévêque
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
CH de Quimper Cornouaille
Quimper, , France
CHU Robert Debre
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut de cancérologie de la Loire
Saint-Priest-en-Jarez, , France
CH Saint Quentin
Saint-Quentin, , France
CHU de Strasbourg
Strasbourg, , France
CHU Purpan
Toulouse, , France
CHU Bretonneau
Tours, , France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Gesundheitszentrum St. Marien GmbH
Amberg, , Germany
Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, , Germany
Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, , Germany
Städt. Klinikum Braunschweig gGmbH
Braunschweig, , Germany
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Bremen, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Marien Hospital Düsseldorf
Düsseldorf, , Germany
St. Antonius Hospital
Eschweiler, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinikum Frankfurt GmbH
Frankfurt (Oder), , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Kath. Krankenhaus Hagen gem. GmbH
Hagen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Klinikum Herford
Herford, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Städt. Klinikum Karlsruhe
Karlsruhe, , Germany
Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel
Kiel, , Germany
Internistische Praxis /Hämatologie und Onkologie
Kronach, , Germany
Onkologisches Zentrum - Lebach
Lebach, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)
Mönchengladbach, , Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Klinikum der Universität München
München, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, , Germany
Universitätsklinikum Münster
Münster, , Germany
Gemeinschaftspraxis für Hämatologie und internistische Onkologie
Neumarkt, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie
Offenbach, , Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Mutterhaus der Borromäerinnen GmbH
Trier, , Germany
University Hospital Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Jeroen Bosch ziekenhuis
's-Hertogenbosch, , Netherlands
MC Alkmaar
Alkmaar, , Netherlands
VUMC
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
AMC
Amsterdam, , Netherlands
Amphia ziekenhuis, locatie Langendijk
Breda, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Gemini Ziekenhuis
Den Helder, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Zuyderland MC
Geleen, , Netherlands
Admiraal De Ruyter Ziekenhuis, Goes
Goes, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
UMCG
Groningen, , Netherlands
Spaarne ziekenhuis
Hoofddorp, , Netherlands
MC Leeuwarden Zuid
Leeuwarden, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Bravis ziekenhuis
Roosendaal, , Netherlands
Erasmus MC - Centrum
Rotterdam, , Netherlands
Erasmus MC - Daniel
Rotterdam, , Netherlands
Maasstadziekenhuis
Rotterdam, , Netherlands
Hagaziekenhuis, locatie Leyweg
The Hague, , Netherlands
St.Elisabeth ZH
Tilburg, , Netherlands
Isala Klinieken, Sophia
Zwolle, , Netherlands
Gdansk University School of Medicine
Gdansk, , Poland
Szpitale Wojewódzkie
Gdynia, , Poland
University Hospital
Krakow, , Poland
Warminsko-Mazurskie Centrum Onkologii
Olsztyn, , Poland
Institute of Hematology and Transfusiology
Warsaw, , Poland
MSCM Institute and Oncology Centre
Warsaw, , Poland
Instituto Português de Oncologia de Lisboa de Francisco Gentil
Lisbon, , Portugal
Hospital Universitario Fundación Alcorcón
Alcorcón, , Spain
Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol
Badalona, , Spain
Hospital Universitario Vall d'hebron
Barcelona, , Spain
Hospital Clínic
Barcelona, , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital Clínico de Salamanca
Salamanca, , Spain
Hospital Clinico de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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MCL R2 Elderly
Identifier Type: -
Identifier Source: org_study_id
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