AzTrials
AzTrials

Marginal Zone LymphomaPhase 3NCT06006117

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

A Phase 3 study testing Mosunetuzumab (SC), Rituximab (R) and Bendamustine in people with Marginal Zone Lymphoma, run by The Lymphoma Academic Research Organisation at 48 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone Lymphoma
What is being tested?
Mosunetuzumab (SC), Rituximab (R) and Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
48 sitesin 5 countries
Study dates
5 Sep 2023to Sep 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Have a biopsy proven diagnosis of MZL, extranodal (EMZL) or nodal (NMZL) Or have a diagnosis of splenic MZL (SMZL) based on mandatory 13 flow cytometry markers: surface immunoglobulins (SmIg), CD5, CD23, FMC7, CD22 or CD79b, CD200, CD180, CD20, CD43, CD11c, CD10,CD103 and CD123 and validated by a centralized review.
  • In case of large dissemination, disseminated MZL (as evaluated by investigator; please contact the Sponsor to discuss any doubt) will be included as DMZL and included in NMZL subtype. Participants with high tumor burden criteria are eligible.
  • Participants with borderline or related entities, such as splenic diffuse red pulp lymphoma (SDRPL), typical hairy cell leukemia (HCL), and HCL variant (HCLv), are not eligible.
  • Have been treated with at least one prior systemic treatment and not more than three prior lines. Previous line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles; participants treated with monoclonal antibody monotherapy should have received at least 4 weekly injections) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as BTK inhibitors (at least 1 month). Participants previously treated by lenalidomide are eligible if the last administration of lenalidomide is superior to 12 months before C1D1. When randomized in comparator arm, those participants should require R-chemo. Prior local therapy (including surgery, radiotherapy antibiotics for H. pylori-positive gastric lymphoma, and antiviral for hepatitis C virus) is not considered as one line of treatment
  • Signed Informed Consent Form
  • Age ≥ 18 years at the time of signing the informed consent form
Show all 27Show fewer
  • Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement
  • Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2
  • Have a symptomatic disease requiring a systemic treatment
  • Not eligible for a local treatment including radiotherapy or surgery
  • Stage I disease of EMZL, SMZL or NMZL may be eligible only if not candidate to local therapy (surgery or radiotherapy).
  • Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with ≥ 15 mm in longest transverse diameter or the short diameter must measure ≥ 10 mm regardless of the longest transverse diameter.
  • Spleen is considered as a measurable disease if vertical axis is higher than 130 mm.
  • Adequate hematopoietic function at screening as follows unless cytopenia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune thrombocytopenia:
  • 11.1. Platelet count ≥ 75 G/L; in cases of thrombocytopenia clearly due to marrow involvement of MZL or hypersplenism or auto-immune thrombocytopenia, platelet count should be ≥ 30 G/L. Washout platelet transfusion is 7 days between transfusion and D1 of starting treatment 11.2. Absolute Neutrophil Count (ANC) ≥ 1 G/L unless neutropenia is clearly due to marrow involvement of MZL or hypersplenism. G-CSF is not allowed within 7 days before starting treatment 11.3. Total hemoglobin ≥ 8 g/dL unless anemia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune hemolytic anemia. Washout erythrocyte transfusion is 7 days between transfusion and D1 of starting treatment
  • Serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN) (or ≤3 x ULN for participants with Gilbert syndrome),
  • AST or ALT ≤ 2.5 x ULN, unless directly attributable to the participant's MZL
  • Measured or estimated creatinine clearance ≥ 40 mL/min by institutional standard method
  • Participants who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation. Participants who are hepatitis B surface antigen (HBsAg) negative, hepatitis B surface antibody (anti-HBsAb) positive and hepatitis B core antibody (HBcAb) negative are eligible,
  • Contraception:
  • 16.1. For women of childbearing potential (WOCBP) (refer to section 14.6.1):
  • must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.
  • must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustine (if applicable) and 12 months after the final dose of rituximab (if applicable).
  • 16.2. For men: with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable). ). Men must also agree to refrain from donating sperm from the first day of treatment until at least 7 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), and 12 months after the final dose of rituximab (if applicable)
  • Participants covered by any social security system (France).
  • Participants who understand and speak one of the country official languages.
  • LVEF within normal range (i.e. > 50% as evaluated by Transthoracic Echocardiography or > 45% as evaluated by isotopic method (MUGA scan)).

Who cannot join

  • MZL with histologic transformation to high-grade lymphoma
  • Participants who have received any of the following treatments prior to study entry:
  • Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
  • Allogeneic stem cell transplant
  • Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:
  • Radiotherapy within 2 weeks prior to the first dose of study treatment
Show all 51Show fewer
  • Autologous stem cell transplant within 100 days prior to first study treatment
  • Use of monoclonal antibodies within 4 weeks prior to first study treatment
  • Systemic immunosuppressive medications (including, but not limited to, Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide, and anti-tumor necrosis factor agents) and corticosteroids on the long run with the following exceptions: inhaled steroids for asthma, topical steroids, or replacement or stress corticosteroids during the study at any time. Participants who require lymphoma symptom control during screening may receive corticosteroid < or = 1mg/kg/day prednisone or equivalent for a maximum of 10 days prior to first dose of study treatment.
  • Any other anti-cancer investigational therapy within 4 weeks prior to initiation of study treatment.
  • Pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of lenalidomide, 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP, 6 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable).
  • Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months after the final dose of study treatment, except for acute pandemic situation such as COVID19
  • Active or history of CNS lymphoma or leptomeningeal infiltration
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) - grade 3 and 4
  • Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including Mannitol
  • Participants unable to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin or low molecular weight heparin or direct oral anticoagulants)
  • History of prior malignancy, except for conditions as listed below if participants have recovered from the acute side effects incurred as a result of previous therapy and only with a single occurrence of the following conditions:
  • Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Surgically/adequately treated low grade, early stage I, localized prostate in situ carcinoma
  • Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to inclusion or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds),
  • Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:
  • Significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure | American Heart Association)], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)
  • Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Known Positive serologic HIV test at screening
  • Acute or chronic hepatitis C virus (HCV) infection Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.
  • Known or suspected history of hemophagocytic lymphohistiocytosis
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection within the last 4 weeks prior to inclusion
  • History of erythema multiforme, Grade ≥3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
  • Active autoimmune disease requiring treatment
  • History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; except:
  • Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
  • Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible
  • Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Medical Monitor.
  • Recent major surgery with risk of bleeding within 4 weeks prior to first study treatment administration (C1D1)
  • History of solid organ transplantation
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
  • Person deprived of his/her liberty by a judicial or administrative decision
  • Person hospitalized without consent
  • Adult person under legal protection
  • Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
  • Participant unable to receive at least one of the three regimens of the comparator arm. As in usual practice, physician has to verify the absence of contraindication to the use of the drugs, hypersensitivity, and to take into account the lymphoma history and previous treatment scheme used
  • Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment (e.g. very high SUV (SUV > 20 or double compared to SUV of other lesions) in at least one lesion that was not biopsied, and discordant with SUV of biopsied lesion, LDH > 2.5 ULN in a context of rapidly progressive disease, etc). Please contact the Coordinating Investigators / Sponsor to discuss such cases or if there is any doubt before considering enrollment.
  • Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment within 48 hours (participants with controlled disease after adequate pleural/serous drainage and/or effective pleurX™ or similar system are eligible only if control system is in place before randomization).
  • Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if control system is in place before randomization).

Trial locations and contacts

48 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Christine STEPHAN contact

04 72 66 38 76

christine.stephan@lysarc.org

48 sites in 5 countries

France23 sites, 23 recruiting

  • CHU d'Amiens

    Amiens

    Caroline DELETTE, MD

    Recruiting

  • CH d'Avignon - Hopital Henri Duffaut

    Avignon

    Hacene ZERAZHI, MD

    Recruiting

  • CH de la Côte Basque - Hôpital de Bayonne

    Bayonne

    Sophie BERNARD, MD

    Recruiting

  • CHRU Besançon - Hôpital Minjoz

    Besançon

    Adrien CHAUCHET, MD

    Recruiting

  • Institut Bergonié

    Bordeaux

    Fontanet BIJOU, Pr

    Recruiting

  • Chu Estaing

    Clermont-Ferrand

    Olivier Tournilhac, MD

    Recruiting

  • CHU Henri Mondor

    Créteil

    Corinne Haioun

    Recruiting

  • CHU de Dijon

    Dijon

    Olivier CASASNOVAS, MD

    Recruiting

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche

    Sylvain CARRAS, MD

    Recruiting

  • CHRU de LILLE - Claude Huriez

    Lille

    Franck MORSHHAUSER, Pr

    Recruiting

  • Institut Paoli Calmette

    Marseille

    Aude Collignon, MD

    Recruiting

  • CH Saint-Eloi

    Montpellier

    Guillaume CARTRON, MD

    Guillaume CARTRON, MD

    Recruiting

  • CHU de Nancy - Brabois

    Nancy, France

    Pierre FEUGIER, MD

    Recruiting

  • Centre Catherine de Sienne

    Nantes

    Nadine Morineau, MD

    Recruiting

  • CHU de Nantes - Hôtel Dieu

    Nantes

    Béatrice MAHE, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Fréderic PEYRADE, Pr

    Recruiting

  • CHU de Nice

    Nice

    Edmond CHICHE, MD

    Recruiting

  • CHR d'Orléans

    Orléans

    Marlène OCHMANN, MD

    Recruiting

  • APHP - Hôpital Saint Louis

    Paris

    Catherine Thieblemont, Pr

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite

    Emmanuel BACHY, MD

    Recruiting

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes

    Roch HOUOT, MD

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Fabrice JARDIN, Pr

    Recruiting

  • Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez

    Ludovic FOUILLET, MD

    Recruiting

Other trials in France

Italy11 sites, 11 recruiting

  • POLICLINICO SANT'ORSOLA-MALPIGHI - Ematologia

    Bologna

    Pier Luigi ZINZANI, Prof.

    Not yet recruiting

  • INSTITUTO ONCOLOGICO VENETO I.R.C.C.S - Ematologia

    Castelfranco Veneto

    Nilla MASCHIO, MD, nilla.maschio@iov.veneto.it

    Not yet recruiting

  • AZIENDA OSPEDALIERA S. CROCE E CARLE CUNEO - Ematologia

    Cuneo

    Elia BOCCELLATO, MD, boccellato.e@ospedale.cuneo.it

    Not yet recruiting

  • SAPIENZA UNIVERSIT DI ROMA - POLO PONTINO - OSPEDALE S. MARIA GORETTI LATINA - UOC Ematologia

    Latina

    Alessandro PULSONI, MD, Alssandro.pulsoni@uniroma1.it

    Not yet recruiting

  • OSPEDALE VITO FAZZI LECCE - Hematologia

    Lecce

    Nicola Last Name, MD, direnzo.ematolecce@gmail.com

    Not yet recruiting

  • OSPEDALE SAN RAFFAELE - Unità di Ricerca Clinica Linfomi Dipartimento di Onco-ematologia

    Milan

    Andrés JM FERRERI, MD, ferreri.andres@hsr.it

    Not yet recruiting

  • AZIENDA OSPEDALIERO UNIVERITARIA DI MODENA - Ematologia

    Modena

    Giovanna LEONARDI, MD, leonardi.giovanna@aou.mo.it

    Not yet recruiting

  • POLICLINICO SAN MATTEO - SC Ematologia

    Pavia

    Luca ARCAINI, MD

    Not yet recruiting

  • OSPEDALE S. MARIA DELLE CROCI - Dipartimento di Oncologia ed Ematologia

    Ravenna

    Monica TANI, MD, monica.tani@auslromagna.it

    Not yet recruiting

  • AOU CITTA DELLA SALUTE E DELLA SCIENZA DI TORINO - Ematologia

    Torino

    Candida VITALE, MD, Candida.vitale@unito.it

    Not yet recruiting

  • OSPEDALE MAGGIORE ASUGI - UCO Ematologia

    Trieste

    Francesco ZAJA, MD, francesco.zaja@asugi.sanita.fvg.it

    Not yet recruiting

Other trials in Italy

Germany9 sites, 9 recruiting

  • KLINIKUM ST. MARIEN AMBERG - Hämatologie/Onkologie

    Amberg

    Ludwig FISCHER VON WEIKERSTHAL, MD, weikersthal.ludwig@klinikum-amberg.de

    Not yet recruiting

  • Helios Klinikum Berlin-Buch - Klinik für Hämatologie und Stammzelltransplantation

    Berlin

    Bertram GLASS, MD, bertram.glass@helios-gesundheit.de

    Not yet recruiting

  • UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - Med. Klinik II - Hämatologie und Onkologie

    Kiel

    Christiane POTT, MD, c.pott@med2.uni-kiel.de

    Not yet recruiting

  • KLINIKUM DER STADT LUDWIGSHAFEN - Hämatologie

    Ludwigshafen

    Martin HOFFMANN, MD, hoffmanM@klilu.de

    Recruiting

  • UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

    Regensburg

    Stephanie MAYER, MD

    Not yet recruiting

  • ROBERT BOSCH KRANKENHAUS - Hämatologie, Onkologie und Palliativmedizin

    Stuttgart

    Nicola GIESEN, MD, nicola.giesen@rbk.de

    Not yet recruiting

  • MUTTERHAUS DER BORROMAERINNEN - Hämatologie

    Trier

    Rolf MAHLBERG, MD, mahlberg@mutterhaus.de

    Not yet recruiting

  • UNIV KLINIKUM ULM - INNERE MEDIZIN III - Hämatologie

    Ulm

    Christian Buske, Prof., christian.buske@uni-ulm.de

    Not yet recruiting

  • UNIVERSITY WURZBURG - Hämatologie

    Würzburg

    Johannes DULL, Prof., Duell_j@ukw.de

    Not yet recruiting

Other trials in Germany

Belgium4 sites, 4 recruiting

  • INSTITUT JULES BORDET - Service Hématologie

    Anderlecht, 1070

    Fulvio MASSARO, MD, 0032 25417214, fulvio.massaro@hubruxelles.be

    Not yet recruiting

  • UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie

    Brussels, 1200

    Sarah BAILLY, MD, 0032 2 764 85 84, sarah.bailly@uclouvain.be

    Not yet recruiting

  • UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie

    Ghent, 9000

    Ciel DE VRIENDT, 0032 9 332 1778, ciel.devriendt@uzgent.be

    Recruiting

  • CHU UCL NAMUR - SITE GODINNE - Service Hématologie

    Yvoir, 5530

    Wivine BERNARD, MD, 0032 81423844, wivine.bernard@chuuclnamur.uclouvain.be

    Not yet recruiting

Other trials in Belgium

Portugal1 site, 1 recruiting

  • INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

    Lisbon, 1099

    Maria GOMES DA SILVA, MD PhD, 00351 21 7229867, mgsilva@ipolisboa.min-saude.pt

    Recruiting

Other trials in Portugal

About this study

Official title: Phase III, Multicenter, Open Label, Randomized, Controlled Study Investigating Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib.

The patients will be Randomized as follows:

Read more

Arm A - Experimental arm:

  • Mosunetuzumab-Lenalidomide

Arm B - Comparator arms ( Investigator Choices):

  • Rituximab-Lenalidomide
  • Rituximab-Bendamustine
  • Rituximab-CHOP
Read the detailed description

This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib.

Patients are stratified according to MZL subtypes and time to progression of disease after first-line within 2 years (POD24) < 2 years or > 2 years.

Mosunetuzumab will be administered sub-cutaneously (SC) (21 days first cycle, then 28 days next cycles) and Lenalidomide will be given PO 20 mg/day from Day 1 to Day 21 from cycles C2 to C6. For each patient, investigator choice had to be decided before randomization between Rituximab-Lenalidomide and Rituximab-chemotherapy (R-Bendamustine or R-CHOP).

The primary efficacy endpoint for comparison is the Progression-free survival (PFS) as determined by investigator (Lugano criteria 2014). Secondary objectives include CR24 as determined by investigator (at 24 months) according to Lugano criteria 2014 and by central review based on PET result, Overall response rate (ORR) and CR other than CR24 as determined by investigator, or by central review based on PET result according to Lugano Criteria 2014. 260 patients are planned to be enrolled in France, Belgium, Germany, Italy and Portugal

Being tested
Mosunetuzumab (SC), Rituximab (R), Bendamustine, CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone), Lenalidomide
Keywords
Bispecific antibodies, Subcutaneous, Step-up dosing, Marginal Zone Lymphoma, Investigator choices, R/R MZL
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • Mosunetuzumab (SC)Drug

    Also called Mosunetuzumab

    ○ Mosunetuzumab will be administered SC (21 days first cycle, then 28 days next cycles)

    • C1 (21-days cycle): step-up dosing schedule 5 mg Day 1, 45 mg on Day 8 and 45 mg Day 15
    • C2 to C12: 45 mg D1 28-days cycles

  • Rituximab (R)Drug

    Also called Rituximab

    Rituximab* 375 mg/m2 intravenously at Day 1 cycle 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2-12

  • BendamustineDrug

    ○ Bendamustine IV 70 or 90 mg/m² (according to the investigator's judgment) D1 and D2/28 days x 6 cycles 28 days cycles). For patients in complete response (CR) at 3 cycles, Bendamustine and Rituximab could be stopped after 4 cycles at investigator discretion

  • CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)Drug

    Also called CHOP

    CHOP, IV standard dose from cycle 1 to 6

  • LenalidomideDrug

    Cycles 2 to 6 (28-day cycles): starting dose is based on patient's creatinine clearance, from day 1 to day 21, once a day, rest period from day 22 to day 28

Study groups in NCT06006117
Study groupRoleWhat they receive
Arm 1: Mosunetuzumab and LenalidomideExperimental* Mosunetuzumab will be administered SC (21 days first cycle, then 28 days next cycles) * C1 (21-days cycle): step-up dosing schedule 5 mg Day 1, 45 mg on Day 8 and 45 mg Day 15 * C2 to C12: 45 mg D1 28-days cycles * Lenalidomide PO starting dose is based on patient's creatinine clearance from Day 1 to Day 21 from cycles C2 to C6 (cycles of 28 days)
Receives: Drug: Mosunetuzumab (SC); Drug: Lenalidomide
Arm 2: Rituximab-Lenalidomide (28-days cycles)Active comparator* Rituximab* 375 mg/m2 intravenously at Day 1 cycle 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2-12 * Lenalidomide PO starting dose is based on patient's creatinine clearance, D1-21 from cycle 1 to cycle 6
Receives: Drug: Rituximab (R); Drug: Lenalidomide
Arm 3: Rituximab-Bendamustine (28-days cycles)Active comparator* Rituximab* 375 mg/m2 intravenously at cycle 1 Day 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2 to 6 (28-days cycles) and then at D1 of three additional 56-days cycles (C7 to C9). For patients in complete response (CR) at 3 cycles, if Bendamustine is stopped, then Rituximab should also be omitted for C5 and C6. * Bendamustine IV 70 or 90 mg/m² (according to the investigator's judgment) D1 and D2/28 days x 6 cycles 28 days cycles). For patients in complete response (CR) at 3 cycles, Bendamustine and Rituximab could be stopped after 4 cycles at investigator discretion
Receives: Drug: Rituximab (R); Drug: Bendamustine
Arm 4: Rituximab-CHOP (21-days cycles)Active comparator* Rituximab* 375 mg/m2 intravenously at Day 1 cycle 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2 to 6 (21-days cycles), and then at D1 of three additional 56-days cycles (C7 to C9) * CHOP, IV standard dose from cycle 1 to 6
Receives: Drug: Rituximab (R); Drug: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)

What is being measured

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

  1. Progression-free survival (PFS) as determined by investigator

    according to Lugano criteria 2014

    Measured: After 122 events = approximately 4.5 years and after 163 events = approximately 6.5 years (event = progression or death)

Secondary outcomes (35)

  1. Complete Response rate (CR) as determined by investigator (CR24)

    according to Lugano criteria 2014

    Measured: 2 years

  2. Complete response rate (CR) by blinded central review (CR24)

    based on PET result according to Lugano Criteria 2014

    Measured: 2 years

  3. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 6 months for patients with Mosunetuzumab-Lenalidomide, Rituximab-Lenalidomide or R-CHOP, 3 months for patients with Rituximab-bendamustine

  4. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 12 months

  5. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 24 months

  6. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 36 months

  7. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 48 months

  8. Overall response rate (ORR) as determined by investigator

    according to Lugano Criteria 2014

    Measured: 60 months

  9. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 6 months for patients with Mosunetuzumab-Lenalidomide, Rituximab-Lenalidomide or R-CHOP, 3 months for patients with Rituximab-bendamustine

  10. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 12 months

  11. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 24 months

  12. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 36 months

  13. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 48 months

  14. Overall response rate (ORR) by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 60 months

  15. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 6 months for patients with Mosunetuzumab-Lenalidomide, Rituximab-Lenalidomide or R-CHOP, 3 months for patients with Rituximab-bendamustine

  16. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 12 months

  17. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 24 months

  18. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 36 months

  19. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 48 months

  20. CR rate other than CR24 as determined by investigator

    according to Lugano Criteria 2014

    Measured: 60 months

  21. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 6 months for patients with Mosunetuzumab-Lenalidomide, Rituximab-Lenalidomide or R-CHOP, 3 months for patients with Rituximab-bendamustine

  22. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 12 months

  23. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 24 months

  24. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 36 months

  25. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 48 months

  26. CR rate other than CR24 by blinded central review

    based on PET result according to Lugano Criteria 2014

    Measured: 60 months

  27. Duration of response (DOR)

    time from the first occurrence of a documented objective response to progression/relapse or death from any cause

    Measured: 6.5 years

  28. Event-free survival (EFS)

    time from the date of randomization to the event of death of from any cause, disease progression or relapse, early discontinuation of the treatment because of any reason or first documented administration of any new anti-lymphoma treatment

    Measured: 6.5 years

  29. Time to next anti-lymphoma treatment (TTNLT)

    time from the date of randomization to the date of first documented administration of any new anti-lymphoma treatment

    Measured: 6.5 years

  30. Histological transformation rate

    percentage of transformation from MZL to diffuse large B-cell lymphoma

    Measured: 6.5 years

  31. Safety: incidence and severity of Adverse Events (AE), of Serious Adverse Events (SAE), of Cytokine Release Syndrome (CRS), of AE grade 3 or 4 of study-drug_related events, incidence of Death and Secondary Primary Malignancies

    Safety described according to actual treatment arm received

    Measured: 6.5 years

  32. Tolerability : number of dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events

    Tolerability described according to actual treatment arm received

    Measured: 6.5 years

  33. Health related quality of life as measured by the EQ-5D-5L

    described by domains (Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression) and with the global score

    Measured: 7 months

  34. Health related quality of life as measured by the EQ-5D-5L

    described by domains (Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression) and with the global score

    Measured: 12 months

  35. Health related quality of life as measured by the EQ-5D-5L

    described by domains (Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression) and with the global score

    Measured: 24 months

Timeline

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

  1. First posted23 Aug 2023
  2. Study start5 Sep 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2032 (estimated)

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
Model description
Arm A - Experimental arm: Mosunetuzumab-Lenalidomide Arm B - Comparator arms (Investigator Choices): * Rituximab-Lenalidomide * Rituximab-Bendamustine * Rituximab-CHOP
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06006117
Sponsor's protocol ID
MARSUN
Status last verified
Mar 2026
First submitted
27 Jul 2023
Last updated
15 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mosunetuzumab (SC), Rituximab (R) and Bendamustine in people with Marginal Zone Lymphoma, run by The Lymphoma Academic Research Organisation at 48 sites in 5 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 27 inclusion and 51 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in France, Italy, Germany, Belgium, Portugal. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Christine STEPHAN (04 72 66 38 76, christine.stephan@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) as determined by investigator (time frame: After 122 events = approximately 4.5 years and after 163 events = approximately 6.5 years (event = progression or death)). 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 NCT06006117.

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 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in