AzTrials
AzTrials

Follicular LymphomaPhase 3MorningLyteNCT06284122

Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

A Phase 3 study testing Mosunetuzumab, Lenalidomide and Rituximab in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 111 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Mosunetuzumab, Lenalidomide and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
790 participants
Where
111 sitesin 7 countries
Study dates
7 Jun 2024to Apr 2034
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

  • 1. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the WHO 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use.
  • FLIPI 2-5.
  • All Ann Arbor stages (including stage I if FLIPI ≥ 2).
  • Must need treatment as evidenced by at least one of the following criteria:
  • 4.1. Bulky disease defined as one of the following: 4.1.1. a nodal or extranodal mass/lesion > 70 mm in its largest diameter or, 4.1.2. involvement of at least 3 different nodal or extranodal sites (each with a diameter greater than > 30 mm) 4.2. Presence of at least one of the following B symptoms within the prior 6 months: 4.2.1. fever (> 38°C) of unclear etiology 4.2.2. night sweats 4.2.3. weight loss greater than 10% 4.3. Symptomatic splenomegaly 4.4. Symptomatic lesion: 4.4.1. painful lesion and/or 4.4.2. any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal) 4.5. Any one of the following cytopenias due to lymphoma: 4.5.1. hemoglobin < 10g/dL (6.25 mmol/L) 4.5.2. platelets <100 x 109/L, or 4.5.3. absolute neutrophil count (ANC) < 1.5 x 109/L 4.6. Pleural or peritoneal serous effusion (irrespective of cell content) 4.7. Abnormal biological prognostic parameters: (item not applicable for Germany) 4.7.1. β2microglobulin > ULN or 4.7.2. LDH > ULN
  • At least one bi-dimensionally measurable nodal lesion, defined as > 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as > 10 mm in its longest dimension (and FDG-avid lesion).
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  • Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.
  • Must be ≥ 18 years old at the time of signing the informed consent form (ICF).
  • ECOG performance status 0 to 2.
  • Estimated minimum life expectancy of 3 months.
  • Adequate hematological function within 28 days prior to randomization, including:
  • 10.1. Absolute neutrophil count (ANC) ≥ 1 x 109/L 10.2. Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration or splenomegaly 10.3. Hemoglobin ≥ 8.0 g/dL (5 mmol/L) unless related to bone marrow infiltration or splenomegaly. Transfusion is allowed before starting treatment (no required window)
  • Normal laboratory values:
  • 11.1. Measured or estimated creatinine clearance ≥ 40mL/min calculated by institutional standard method (MDRD or Cockcroft-Gault 11.2. AST or ALT ≤ 2.5 x the upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 5 x ULN 11.3. Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbert syndrome), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 3 x ULN
  • LVEF within normal range (i.e. > 50% as evaluated by Transthoracic Echocardiography or > 45% as evaluated by isotopic method (MUGA scan).
  • Participants should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants).
  • Patients with a curative anticoagulation therapy can be enrolled. A patient with deep vein thrombosis due to compressive syndrome is eligible if a curative anticoagulation therapy has been started at least 1 week before initiating study treatment: low molecular weight heparin possible at treatment onset, then direct oral anticoagulants according to local practices.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • No more applicable following SM#14
  • Negative HIV test before randomization, with the following exception:
  • Patients with a positive HIV test before randomization are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
  • For women of childbearing potential (WOCBP) :
  • 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), 12 months after the final dose of rituximab (if applicable), and 18 months after the final dose of obinutuzumab (if applicable).
  • 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 07 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), 12 months after the final dose of rituximab (if applicable), and 3 months after the final dose of obinutuzumab (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), 12 months after the final dose of rituximab (if applicable), and 3 months after the last dose of obinutuzumab (if applicable).
  • Participant covered by any social security system (France).
  • Participant who understands and speaks one of the country official languages, unless local regulation authorizes independent translators.

Who cannot join

  • Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13
  • Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.
  • Examples: patients with high or intermediate high SUV (>20) in any nodal or extranodal site particularly in the bones (vertebrae etc) unless biopsy proven to be genuine FL grade 1,2, 3A ; and/or discordant (e.g. SUV doubled) with SUV of other sites including the biopsy site.; and/or LDH > 2.5 x ULN in a context of rapidly progressive disease, etc. Please contact the Coordinating Investigator / Sponsor to discuss such cases or if there is any doubt before considering enrolment.
  • Prior localized radiotherapy for the FL.
  • Prior history of another lymphoma.
  • Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after Coordinating investigator / sponsor approval once confirmed participant is durably asymptomatic after adequate pleural/serous drainage or only if an efficient drainage device (e.g.pleurX™) is in place before randomization.
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  • 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 urinary catheter is in place before randomization.
  • Presence or history of symptomatic or threatening lymphomatous epidural/nerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible.
  • Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.
  • Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs)
  • 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
  • Received a live, attenuated vaccine within 4 weeks before the 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.
  • Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent.
  • Seropositive for or active viral infection with hepatitis B virus (HBV):
  • HBsAg positive
  • HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (Patients who are HBsAg negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible. They should be treated and perform testing at regular interval described in section Anti infectious prophylaxis; Patients who are seropositive due to a history of hepatitis B vaccine (anti-HBs positive) are eligible).
  • Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who are positive for HCV antibody with a negative viral RNA are eligible).
  • Known or suspected hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the excipients.
  • History of solid organ transplantation or allogeneic stem cell transplant (SCT).
  • 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, uveitis, or glomerulonephritis.
  • 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.
  • 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 Coordinating investigator.
  • Participants with any active infection such as known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds), known or suspected chronic active Epstein-Barr virus (EBV) infection are excluded.
  • 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 central nervous system (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 or suspected history of hemophagocytic lymphohistiocytosis (HLH).
  • History of erythema multiforme, Grade ≥3 rash, or blistering rash following prior treatment with immunomodulatory derivatives.
  • History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis.
  • Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease and therapy for ≥ 3 years. However, patients with a single occurrence of the following conditions that have been treated with curative intent are eligible:
  • Localized non-melanoma skin cancer.
  • Carcinoma in situ of the cervix.
  • Carcinoma in situ of the breast.
  • Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer.
  • Presence or history of CNS or meningeal involvement by lymphoma.
  • Pregnant, planning to become pregnant or lactating WOCBP.
  • Any significant medical conditions, including the presence of laboratory abnormality or psychiatric illness which places the patient at unacceptable risk if he/she were to participate in the study, and likely to interfere with participation in this clinical study (according to the investigator's decision) or which confounds the ability to interpret data from the study.
  • Person deprived of his/her liberty by a judicial or administrative decision.
  • Person hospitalized without consent.
  • Adult person under legal protection.
  • Patients with absolute lymphocyte count > 20 G/L before randomization. Participants circulating lymphoma cell≥ 5 G/L must be discussed with the Sponsor before randomization.
  • NB: for 29-31., if there is an individual benefit for such patients, an Ethics Committee will have to be informed case by case.

Trial locations and contacts

111 sites in 7 countries.

111 sites in 7 countries

France37 sites

  • CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie

    Avignon, 84000

  • CH DE LA COTE BASQUE - Service Hématologie

    Bayonne, 64100

  • CHU JEAN MINJOZ - Service Hématologie

    Besançon, 25030

  • INSTITUT BERGONIE - Service d'Oncologie Médicale

    Bordeaux, 33076

  • CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie

    Cahors, 46005

  • CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie

    Chambéry, 73011

  • CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique

    Clermont-Ferrand, 63003

  • HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes

    Créteil, 94010

  • CHU DIJON BOURGOGNE - Service Hématologie Clinique

    Dijon, 21000

  • CHD DE VENDEE - Service Hématologie

    La Roche-sur-Yon, 85925

  • CHU DE GRENOBLE - Service Hématologie

    La Tronche, 38700

  • HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie

    Lille, 59020

  • CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie

    Lille, 59037

  • CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire

    Limoges, 87042

  • INSTITUT PAOLI CALMETTES - Service Hématologie

    Marseille, 13273

  • CHU DE MONTPELLIER - Département d'Hématologie Clinique

    Montpellier, 34090

  • GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie

    Mulhouse, 68100

  • CHU DE NANTES - Service Hématologie

    Nantes, 44093

  • CENTRE HOSPITALIER DE NIORT - Médecine interne

    Niort, 79021

  • HOPITAL SAINT-LOUIS - Service Hématologie

    Paris, 75475

  • CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire

    Pessac, 33604

  • CHU LYON-SUD - Hématologie

    Pierre-Bénite, 69495

  • CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie

    Poissy, 78303

  • CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire

    Poitiers, 86021

  • CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie

    Pringy, 74374

  • CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie

    Reims, 57092

  • CHU PONTCHAILLOU - Hématologie Clinique

    Rennes, 35033

  • CENTRE HENRI BECQUEREL - Service Hématologie

    Rouen, 76038

  • INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie

    Saint-Cloud, 92210

  • Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie

    Saint-Priest-en-Jarez, 42270

  • INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique

    Strasbourg, 67033

  • IUCT ONCOPOLE - Service Hématologie

    Toulouse, 31059

  • CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire

    Tours, 37044

  • CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie

    Valenciennes, 59322

  • CHU BRABOIS - Service Hématologie

    Vandœuvre-lès-Nancy, 54511

  • CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie

    Vannes, 56017

  • GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique

    Villejuif, 94085

Other trials in France

Germany35 sites

  • GESUNDHEITSZENTRUM ST. MARIEN GMBH - Hämatologie/Onkologie

    Amberg, 92224

  • SOZIALSTIFTUNG BAMBERG - KLINIKUM AM BRUDERWALD - Hämatologie und internistische Onkologie

    Bamberg, 96049

  • VIVANTES KLINIKUM AM URBAN - Hämatologie und Onkologie

    Berlin, 10967

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

    Berlin, 13125

  • CHARITE UNIVERSITATSMEDIZIN BERLIN - Med. Klinik m. S. Hämatologie, Onkologie, Tumorimmunologie

    Berlin, 13353

  • KLINIKUM BREMEN-MITTE - Gesundheit Nord gGmbH - Hämatologisch-Onkologische Tagesklinik

    Bremen, 28205

  • KLINIKUM CHEMNITZ GGMBH - Klinik f. Innere Medizin III

    Chemnitz, 9116

  • UNIVERSITÄTSKLINIK DÜSSELDORF-Klinik für Hämatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225

  • GOETHE UNIVERSITÄT FRANKFURT - Medizinische Klinik II Onkologie

    Frankfurt

  • MEDICAL CENTER - UNIVERSITY OF FREIBURG - Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

    Freiburg im Breisgau, 79106

  • GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizinisched Onkologie

    Göttingen, 37075

  • UNIVERSITATSKLINIKUM HALLE (SAALE) - Klinik für Innere Medizin IV

    Halle, 6097

  • KLINIKUM REGION HANNOVER GMBH KLINIK FÜR HÄMATOLOGIE-Onkologie und immunologie

    Hanover, 30459

  • UNIVERSITÄTSKLINIKUM HEIDELBERG - Innere Medizin V

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes - Klinik für Innere Medizin I - Onkologie, Hämatol. Immun. & Rheumatololgie

    Homburg, 66421

  • UNIVERSITÄTSKLINIKUM JENA-Klinik für Innere Medizin II

    Jena, 07747

  • WESTPFALZ KLINIKUM - Klinik für Innere Medizin I

    Kaiserslautern, 67655

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

    Kiel, 24105

  • GEMEINSCHAFTSKLINIKUM MITTELRHEIN GGMBH - Innere Medizin - Hämatologie/Onkologie

    Koblenz, 56073

  • LAKUMED KLINIKUM - Onkologisches und palliativmedizinisches Netzwerk Landshut

    Landshut, 84036

  • UNIVERSITATSKLINIKUM LUBECK - Klinik für Hämatologie und Onkologie

    Lübeck, 23538

  • KLINIKEN MARIA HILF GMBH KRANKENHAUS ST. FRANZISK - Hämatologie, Onkologie & Gastroenterologie

    Mönchengladbach, 41063

  • KLINIKUM GROSSHADERN DER LMU MUNCHEN - Hämatologie und Onkologie allgemein

    München, 81377

  • KLINIKUM RECHTS DER ISAR, III MED KLINIK DER TU - Hämatologie und Onkologie

    München, 81675

  • Gemeinschaftspraxis Fur Hamatologie Und Onkologie

    Münster, 48149

  • Universtatsklinikum Munster

    Münster, 48149

  • BRUEDERKRANKENHAUS ST. JOSEF PADERBORN - Klinik für Hämatologie und Onkologie

    Paderborn, 33098

  • MVZ FÜR HÄMATOLOGIE UND ONKOLOGIE RAVENSBURG GMBH - Hematology

    Ravensburg, 86212

  • UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

    Regensburg, 93053

  • KLINIKUM AM STEINENBERG REUTLINGEN GMBH - Medizinische Klinik I

    Reutlingen, 72764

  • UNIVERSITÄT ROSTOCK - Hämatologie/Onkologie

    Rostock, 18057

  • AGAPLESION DIAKONIEKLINIKUM ROTENBURG - Klinik für Hämatologie, Onkologie und Nephrologie

    Rotenburg (Wümme), 27356

  • UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie

    Ulm, 89081

  • HELIOS UNIVERSITÄTSKLINIKUM WUPPERTAL - Hämatologie und Onkologie

    Wuppertal, 42283

  • UNIVERSITY WURZBURG - Hämatologie

    Würzburg, 97080

Other trials in Germany

Spain16 sites

  • HOSPITAL UNIVERSITARIO DE ALBACETE-Servicio de Hematologia

    Albacete, 02006

  • HOSPITAL DURAN I REYNALS - ICO Oncologia

    Barcelona, 08908

  • HOSPITAL DE LA SANTA CREU I SANT PAU - Servicio de Hematología

    Barcelona, 8025

  • HOSPITAL VALL D'HEBRON - Hematology Service

    Barcelona, 8035

  • HOSPITAL CLINIC BARCELONA - Hematology department

    Barcelona, 8036

  • HOSPITAL UNIVERSITARIO DR. NEGRIN-Servicio de Hematologia

    Las Palmas de Gran Canaria, 35010

  • HOSPITAL UNIVERSITARIO ARNAU DE VILANOVA - Servicio Hematologia

    Lleida, 25198

  • HOSPITAL UNIVERSITARIO DE LA PRINCESA - Hematología

    Madrid, 28006

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON - Servicio de Hematología-UTMO

    Madrid, 28007

  • HOSPITAL 12 DE OCTUBRE - Servicio de Hematología y Hemoterapia

    Madrid, 28041

  • HOSPITAL PUERTA DEL HIERRO - Servicio Hematologia

    Madrid, 28222

  • HOSPITAL UNIVERSITARIO FUNDACION ALCORCON - Consulta de Hematología Hospital de Día Médico

    Madrid, 28922

  • HOSPITAL COSTA DEL SOL MARBELLA - Servicio de hematologia

    Marbella, 29603

  • HOSPITAL CENTRAL ASTURIAS - Servicio de Hematología

    Oviedo, 33011

  • HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia

    Salamanca, 37007

  • HOSPITAL CLINICO DE VALENCIA - Servicio de Hematologia

    Valencia, 46010

Other trials in Spain

Austria8 sites

  • Krankenhaus der Barmherzigen Brüder Graz - Abteilung Für Innere Medizin I

    Graz, 8020

  • Krems University Hospital - Abteilung Für Innere Medizin 2

    Krems, 3500

  • LKH HOCHSTEIERMARK - Department für Hämato-Onkologie

    Leoben, 8700

  • Kepler Universitaetsklinikum - Univ.-Klinik für Hämatologie und Internistische Onkologie

    Linz, 4021

  • Paracelsus Medical University - 3rd Medical Department

    Salzburg, 5020

  • Univ. Klinikum ST.PÖLTEN - Klinische Abteilung Für Innere Medizin 1

    Sankt Pölten, 3100

  • Medical University of Vienna - Department of Hematology and Hemostaseology

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GMBH - IVth Internal Department

    Wels, 4600

Other trials in Austria

Belgium8 sites

  • AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie

    Bruges, 8000

  • INSTITUT JULES BORDET - Service Hématologie

    Brussels, 1070

  • UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie

    Brussels, 1200

  • GRAND HOPITAL DE CHARLEROI - Service Hématologie

    Charleroi, 6000

  • UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie

    Ghent, 9000

  • HELORA - Hôpital de La Louvière - Site Jolimont - Service Hématologie Clinique

    La Louvière, 7100

  • CHU DE LIEGE - Service Hématologie

    Liège, 4000

  • CHU UCL NAMUR - SITE GODINNE - Service Hématologie

    Yvoir, 5530

Other trials in Belgium

Switzerland6 sites

  • Oncology Institute of Southern Switzerland (IOSI) - Department of Oncology

    Bellinzona, 6500

  • Kantonsspital Graubunden - Departement Innere Medizin Medizinische Onkologie und Hämatologie

    Chur, 7000

  • Hôpitaux Universitaires de Genève (HUG) - Hématologie

    Geneva, 1205

  • Kantonsspital Olten - Hämatologie

    Olten, 4600

  • Spital STS AG - Onkologie und Hämatologiezentrum

    Thun, 3600

  • HFR Fribourg - Hématologie

    Villars-sur-Glâne, 1752

Other trials in Switzerland

Portugal1 site

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

    Lisbon, 1099

Other trials in Portugal

About this study

Official title: A Phase III Randomized, Open-label, International, Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.

Read the detailed description

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated Follicular Lymphoma International Prognostic Index (FLIPI) 2-5 follicular lymphoma This study is composed of a screening period (up to 6 weeks before randomization, i.e., 42 days), a treatment period (30 months i.e., 125w), a safety follow-up period (90 days i.e., 3 months), and a survival follow-up period (up to 7 years after the last randomized patient). The enrollment will last approximately 34 months. The total duration of the study will be therefore approximately 10 years.

Once a patient provides written consent, they may enter the screening phase, with a duration up to 6 weeks prior to randomization and initiation of treatment.

Upon completion of the required assessments in the screening phase, and fulfillment of the eligibility criteria, patients will be randomized. Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization.

The treatment period for each patient starts with the first intake. The patients will receive protocol-specified treatments until:

  • inability to achieve a response at the end of induction phase (at M12 evaluation for experimental arm, and at M6 evaluation for control arms),
  • relapse or progression of the disease,
  • withdrawal of consent,
  • or unacceptable toxicity

In the experimental arm, patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide (47 weeks, around 11 months) during the induction phase, and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase (72 weeks, around 17 months), up to around 125 weeks (30 months). Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle (C12).

In the control arm, patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb +cyclophosphamide-doxorubicine-vincristine-prednisone (CHOP) or anti-CD20 mAb + Bendamustine, respectively, depending on the assigned arm (24 weeks, around 5 months) during the induction phase, and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase (96 weeks, around 22 months), up to around 125 weeks (30 months). Patients should start the maintenance phase, 6 to 7 or 7 to 8 weeks after the start of last induction cycle (C8 or C6).

The option to cross-over from the control arm to the experimental arm is not allowed.

All randomized patients will be followed for progression-free survival and overall survival using the same schedule. Patients will be followed up from End of treatment evaluation every 3 months during the first two years, then every 6 months during the next 3 years, then yearly until the end of study.

The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years (or discontinued study early).

Being tested
Mosunetuzumab, Lenalidomide, Rituximab, Obinutuzumab, Cyclophosphamide
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • MosunetuzumabDrug

    5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to C12, 45 mg Day 1 from C13 to C21

  • LenalidomideDrug

    Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12

  • RituximabDrug

    when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C20

  • ObinutuzumabDrug

    when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C18

  • CyclophosphamideDrug

    750 mg/m2 Day 1 from C1 to C6

  • DoxorubicinDrug

    50 mg/m2 Day 1 from C1 to C6

  • VincristinDrug

    1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6

  • PrednisoneDrug

    100 mg/day Day 1 to Day 5 from C1 to C6

  • RituximabDrug

    when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18

  • ObinutuzumabDrug

    when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20

  • BendamustinDrug

    90 mg/m2 Day 1 and Day 2 from C1 to C6

Study groups in NCT06284122
Study groupRoleWhat they receive
Mosun-LenExperimentalMosunetuzumab + lenalidomide
Receives: Drug: Mosunetuzumab; Drug: Lenalidomide
R-CHOPActive comparatorRituximab-CHOP
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisone
G-CHOPActive comparatorObinutuzumab-CHOP
Receives: Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisone
R-BendaActive comparatorRituximab-Bendamustin
Receives: Drug: Rituximab; Drug: Bendamustin
G-BendaActive comparatorObinutuzumab-Bendamustin
Receives: Drug: Obinutuzumab; Drug: Bendamustin

What is being measured

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

  1. Progression Free Survival (PFS)

    time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

    Measured: 130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)

  2. Progression Free Survival (PFS)

    time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

    Measured: 173 PFS events assessed by IRC (5.8 y)

Secondary outcomes (35)

  1. Overall Response (OR)

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 6 months

  2. Complete Metabolic Rate (CMR)

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 6 months

  3. Overall Response (OR)

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 12 months

  4. Complete Metabolic Rate (CMR)

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 12 months

  5. Overall Response (OR) and Complete Response (CR) rate at EOT

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 4.6 years

  6. Best Overall Response (CR or PR) rate

    by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

    Measured: 5.8 years

  7. Progression of disease within 2 years (POD24)

    rate of progression of disease (POD) within 2 years of first line therapy

    Measured: 2 years

  8. PFS

    by Lugano 2014, assessed by investigator

    Measured: 4.6 years

  9. PFS

    by Lugano 2014, assessed by investigator

    Measured: 5.8 years

  10. Event Free Survival (EFS) by Lugano 2014

    time between randomization and date of first documented disease progression/relapse, initiation of a new anti-lymphoma treatment or death from any cause

    Measured: 4.6 years

  11. Event Free Survival (EFS) by Lugano 2014

    time between randomization and date of first documented disease progression/relapse, initiation of a new anti-lymphoma treatment or death from any cause

    Measured: 5.8 years

  12. Time to Next Anti-Lymphoma Treatment (TTNLT)

    time between randomization and date of first documented administration of any new anti-lymphoma treatment

    Measured: 4.6 years

  13. Time to Next Anti-Lymphoma Treatment (TTNLT)

    time between randomization and date of first documented administration of any new anti-lymphoma treatment

    Measured: 5.8 years

  14. Duration of response

    defined for patients with a best overall response of CR or PR determined by Lugano 2014 (PET-CT based response), defined as the time of 1st occurrence of CR or PR to disease progression/relapse or death from any cause

    Measured: 4.6 years

  15. Duration of response

    defined for patients with a best overall response of CR or PR determined by Lugano 2014 (PET-CT based response), defined as the time of 1st occurrence of CR or PR to disease progression/relapse or death from any cause

    Measured: 5.8 years

  16. Overall Response (OR)

    assessed by investigator and IRC

    Measured: End of treatment (12 months for experimental arm, 6 months for comparative arms)

  17. Duration of complete response

    for patients with a best overall response of CR determined by Lugano 2014 (PET-CT based response), define as the time of first occurrence of CR to disease progression/relapse or death from any cause

    Measured: 4.6 years

  18. Duration of complete response

    for patients with a best overall response of CR determined by Lugano 2014 (PET-CT based response), define as the time of first occurrence of CR to disease progression/relapse or death from any cause

    Measured: 5.8 years

  19. Overall Survival (OS)

    time from randomization to death from any cause

    Measured: 4.6 years

  20. Overall Survival (OS)

    time from randomization to death from any cause

    Measured: 5.8 years

  21. Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs)

    Measured: 4.6 years

  22. Incidence and severity of AEs including SAEs and AESIs

    Measured: 5.8 years

  23. Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation

    Measured: 4.6 years

  24. Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation

    Measured: 5.8 years

  25. Incidence of Second Primary Malignancies (SPM)

    Measured: 4.6 years

  26. Incidence of Second Primary Malignancies (SPM)

    Measured: 5.8 years

  27. anti-drug antibodies (ADA) to mosunetuzumab

    Measured: each cycle, 18 months, 24 months, 30 months

  28. Time to deterioration in physical functioning

    EORTC QLQ-C30 quality of life questionnaire

    Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment

  29. Time to deterioration in lymphoma symptoms

    FACTLym LYMS quality of life questionnaire

    Measured: baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment

  30. Maximum serum concentration of mosunetuzumab - Cmax

    Measured: each cycle, 18 months, 24 months, 30 months

  31. Minimum serum concentration of mosunetuzumab - Cmin

    Measured: each cycle, 18 months, 24 months, 30 months

  32. Area under the curve of serum concentration of mosunetuzumab - AUC

    Measured: each cycle, 18 months, 24 months, 30 months

  33. Maximum serum concentration of lenalidomide - Cmax

    Measured: each cycle, 18 months, 24 months, 30 months

  34. Minimum serum concentration of lenalidomide - Cmin

    Measured: each cycle, 18 months, 24 months, 30 months

  35. Area under the curve of serum concentration of lenalidomide - AUC

    Measured: each cycle, 18 months, 24 months, 30 months

Timeline

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

  1. First posted28 Feb 2024
  2. Study start7 Jun 2024
  3. Primary completionNov 2028 (estimated)
  4. Study completionApr 2034 (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
Masking
None (open label)
Enrolment
790 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06284122
Sponsor's protocol ID
MorningLyte
Acronym
MorningLyte
Status last verified
Sep 2026
First submitted
14 Feb 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mosunetuzumab, Lenalidomide and Rituximab in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 111 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 27 inclusion and 47 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in France, Germany, Spain, Austria, 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?

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?

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 (PFS) (time frame: 130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)). The study lists 2 primary outcomes in all. 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 NCT06284122.

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 25 Sep 2026.

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