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Mantle Cell LymphomaPhase 3NCT01865110

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

A Phase 3 study testing R-CHOP, R-CHOP / R-HAD and Rituximab in people with Mantle Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 143 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
R-CHOP, R-CHOP / R-HAD and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
623 participants
Where
143 sitesin 7 countries
Study dates
Nov 2013to 31 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

143 sites in 7 countries.

143 sites in 7 countries

France56 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49000

  • CH d Avignon - Hopital Henri Duffaut

    Avignon, 84902

  • CH Côte Basque

    Bayonne, 64100

  • CHU Jean Minjoz

    Besançon, 25030

  • CH de Blois

    Blois, 41000

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord

    Bordeaux, 33300

  • CH du Dr Duchenne

    Boulogne-sur-Mer, 62321

  • CHU Morvan

    Brest, 29609

  • CHU Caen

    Caen, 14000

  • MEDIPOLE de SAVOIE

    Challes-les-Eaux, 73190

  • CHU de Châlon-sur-Sâone - William Morey

    Châlon-sur-Sâone, 71000

  • CH Chambéry

    Chambéry, 73011

  • Hopital Antoine Beclere

    Clamart, 92140

  • CHU Estaing

    Clermont-Ferrand, 63000

  • Pôle Santé République

    Clermont-Ferrand, 63050

  • CH Sud Francilien de Corbeil

    Corbeil-Essonnes, 91108

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU Le Bocage

    Dijon, 21034

  • CH Dunkerque

    Dunkirk, 59385

  • Institut Daniel Hollard

    Grenoble, 38028

  • CHU de Grenoble

    Grenoble, 38043

  • CH Départemental

    La Roche-sur-Yon, 85925

  • Groupe Hospitalier La Rochelle - Ré - Aunis

    La Rochelle, 17019

  • Hôpital André Mignot

    Le Chesnay, 78157

  • CH du Mans

    Le Mans, 72000

  • Clinique Victor Hugo

    Le Mans, 72000

  • CH de Lens

    Lens, 62300

  • CHU Claude Hurriez

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmette

    Marseille, 13273

  • CH de Meaux

    Meaux, 77104

  • Hôpital Bon Secours

    Metz, 57038

  • CH de la Région Annecy-Genevois

    Metz-Tessy, 74374

  • CHU Montpellier

    Montpellier, 34295

  • CHU Hôtel Dieu

    Nantes, 44093

  • CHR de la Source

    Orléans, 45067

  • Hopital Saint Antoine

    Paris, 75012

  • Hôpital Saint Louis

    Paris, 75475

  • Hôpital de la Pitié Salpêtrière

    Paris, 75651

  • Hôpital Necker

    Paris, 75743

  • CH Perpignan

    Perpignan, 66046

  • Hôpital Haut Lévêque

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CH de Quimper Cornouaille

    Quimper, 29107

  • CHU Robert Debre

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • CH Saint Quentin

    Saint-Quentin, 02321

  • CHU de Strasbourg

    Strasbourg, 67098

  • CHU Purpan

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37044

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany35 sites

  • Gesundheitszentrum St. Marien GmbH

    Amberg, 92224

  • Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12200

  • Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum

    Berlin, 13353

  • Städt. Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

    Bremen, 28239

  • Klinikum Chemnitz gGmbH

    Chemnitz, 9116

  • Universitätsklinikum Köln

    Cologne, 50937

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

  • St. Antonius Hospital

    Eschweiler, 52249

  • Universitätsklinikum Essen

    Essen, 45147

  • Klinikum Frankfurt GmbH

    Frankfurt (Oder)

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Kath. Krankenhaus Hagen gem. GmbH

    Hagen, 58095

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Klinikum Herford

    Herford, 32049

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Städt. Klinikum Karlsruhe

    Karlsruhe, 76133

  • Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel

    Kiel, 24116

  • Internistische Praxis /Hämatologie und Onkologie

    Kronach, 96317

  • Onkologisches Zentrum - Lebach

    Lebach, 66822

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

    Mönchengladbach, 41063

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Klinikum der Universität München

    München, 83177

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48149

  • Universitätsklinikum Münster

    Münster, 48149

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • Gemeinschaftspraxis für Hämatologie und internistische Onkologie

    Neumarkt, 92318

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie

    Offenbach, 63065

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098

  • Universitätsklinik Rostock

    Rostock, 18057

  • Mutterhaus der Borromäerinnen GmbH

    Trier, 54219

  • University Hospital Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Netherlands25 sites

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch, 5200 ME

  • MC Alkmaar

    Alkmaar, 1800AM

  • VUMC

    Amsterdam, 1007 MB

  • OLVG

    Amsterdam, 1090 HM

  • AMC

    Amsterdam, 1100 DD

  • Amphia ziekenhuis, locatie Langendijk

    Breda, 4800 RL

  • Reinier de Graaf Gasthuis

    Delft, 2600 GA

  • Gemini Ziekenhuis

    Den Helder, 1780 AT

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Zuyderland MC

    Geleen, 6130 MB

  • Admiraal De Ruyter Ziekenhuis, Goes

    Goes, 4460 BB

  • Groene Hart Ziekenhuis

    Gouda, 2800 BB

  • UMCG

    Groningen, 9700 RB

  • Spaarne ziekenhuis

    Hoofddorp, 2130 AT

  • MC Leeuwarden Zuid

    Leeuwarden, 8901 BR

  • Maastricht UMC

    Maastricht, 6202 AZ

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3430 EM

  • Radboudumc

    Nijmegen, 6525 GA

  • Bravis ziekenhuis

    Roosendaal, 4700 AZ

  • Erasmus MC - Centrum

    Rotterdam, 3000 CA

  • Erasmus MC - Daniel

    Rotterdam, 3008 AE

  • Maasstadziekenhuis

    Rotterdam, 3079 DZ

  • Hagaziekenhuis, locatie Leyweg

    The Hague, 2504 LN

  • St.Elisabeth ZH

    Tilburg, 5000 LC

  • Isala Klinieken, Sophia

    Zwolle, 8000 GK

Other trials in Netherlands

Spain11 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol

    Badalona, 8916

  • Hospital Universitario Vall d'hebron

    Barcelona, 8035

  • Hospital Clínic

    Barcelona, 8036

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • Hospital Clínico de Salamanca

    Salamanca, 37007

  • Hospital Clinico de Valencia

    Valencia, 46010

Other trials in Spain

Belgium9 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • A. Z. Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Université Catholique de Louvain Saint Luc

    Brussels, 1200

  • Grand Hopital de Charleroi

    Charleroi, 6000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU de Liège

    Liège, 4000

  • CH de la Tourelle-Peltzer

    Verviers, 4800

  • Université Catholique de Louvain Mont Godinne

    Yvoir

Other trials in Belgium

Poland6 sites

  • Gdansk University School of Medicine

    Gdansk, 80-211

  • Szpitale Wojewódzkie

    Gdynia, 81-519

  • University Hospital

    Krakow, 31-501

  • Warminsko-Mazurskie Centrum Onkologii

    Olsztyn, 10-228

  • Institute of Hematology and Transfusiology

    Warsaw, 02-776

  • MSCM Institute and Oncology Centre

    Warsaw, 02-781

Other trials in Poland

Portugal1 site

  • Instituto Português de Oncologia de Lisboa de Francisco Gentil

    Lisbon, 1099-023

Other trials in Portugal

About this study

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

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).

Read the 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.

Being tested
R-CHOP, R-CHOP / R-HAD, Rituximab, Lenalidomide
Keywords
Mantle Cell Lymphoma, RCHOP, RHAD, rituximab, lenalidomide
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CHOPDrug

    Also called rituximab, CHOP

    R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles

  • R-CHOP / R-HADDrug

    Also called rituximab, CHOP, rituximab HD AraC

    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

  • RituximabDrug

    Also called Mabthera

    Rituximab SC 1400 mg every 8 weeks for 24 months

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months

Study groups in NCT01865110
Study groupRoleWhat they receive
Induction experimental armExperimentalR-CHOP / R-HAD : Alternating 3 cycles of R-CHOP administered in 3 week cycles + 3 cycles of R-HAD administered in 4 week cycles.
Receives: Drug: R-CHOP / R-HAD
Standart induction armActive comparator8 cycles of R-CHOP administered in 3 week cycles
Receives: Drug: R-CHOP
Maintenance experimental armExperimentallenalidomide + 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
Receives: Drug: Rituximab; Drug: Lenalidomide
Maintenance standart armActive comparator13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    2.5 years after last patient randomized in maintenance

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion30 Nov 2020
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865110
Sponsor's protocol ID
MCL R2 Elderly
Status last verified
Mar 2025
First submitted
24 May 2013
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-CHOP, R-CHOP / R-HAD and Rituximab in people with Mantle Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 143 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in France, Germany, Netherlands, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01865110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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