A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma (Celestimo)

Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Follicular Lymphoma
• Intervention / Treatment: Drug: Mosunetuzumab; Drug: Lenalidomide; Drug: Tociluzumab; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID: GO42909 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Active, not recruiting
      • Calvary Mater Newcastle
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Active, not recruiting
      • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Active, not recruiting
      • Royal Adelaide Hospital; Haematology Clinical Trials
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Active, not recruiting
      • Geelong Hospital; Andrew Love Cancer Centre
• Brazil
  • PR
    • Curitiba, PR, Brazil, 80510-130
      • Active, not recruiting
      • ICTR Curitiba
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Active, not recruiting
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90110-000
      • Active, not recruiting
      • Hospital Mãe de Deus
  • SP
    • Sao Paulo, SP, Brazil, 01323-903
      • Active, not recruiting
      • Hospital Alemao Oswaldo Cruz
• China
  • Beijing, China, 100142
    • Active, not recruiting
    • Beijing Cancer Hospital
  • Beijing, China, 100191
    • Active, not recruiting
    • Peking University Third Hospital
  • Beijing City, China, 100034
    • Recruiting
    • Peking University First Hospital
  • Changchun City, China, 130021
    • Recruiting
    • The First Hospital of Jilin University
  • Guangzhou City, China, 510060
    • Recruiting
    • Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
  • Harbin, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Nanchang, China, 330019
    • Recruiting
    • The 1st Affiliated Hospital of Nanchang Unversity
  • Nanjing, China, 210008
    • Active, not recruiting
    • Jiangsu Province Hospital
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai City, China, 201315
    • Recruiting
    • Fudan University Shanghai Cancer Center; Medical Oncology
  • Tianjin, China, 300060
    • Active, not recruiting
    • Tianjin Cancer Hospital
  • Tianjin City, China, 300020
    • Recruiting
    • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • Wuhan City, China, 430023
    • Active, not recruiting
    • Union Hospital Tongji Medical College Huazhong University of science and Technology
  • Wuhan City, China, 430030
    • Recruiting
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xiamen, China, 361003
    • Active, not recruiting
    • The First Affiliated Hospital of Xiamen University
  • Zhejiang, China, 310022
    • Recruiting
    • Zhejiang Cancer hospital
  • Zhengzhou, China, 450052
    • Recruiting
    • The First Affiliated hospital of Zhengzhou University
• France
  • Bayonne, France, 64109
    • Active, not recruiting
    • Centre Hospitalier de La Cote Basque; Hematologie
  • Chambery, France, 73011
    • Active, not recruiting
    • Ch De Chambery; Hematologie Oncologie
  • Creteil, France, 94010
    • Active, not recruiting
    • Hopital Henri Mondor; Hematologie Clinique
  • Lille, France, 59037
    • Active, not recruiting
    • Hopital Claude Huriez; Hematologie
  • Marseille, France, 13009
    • Active, not recruiting
    • Institut Paoli Calmettes
  • Montpellier, France, 34295
    • Active, not recruiting
    • CHU Saint Eloi; Service d'Hématologie Clinique
  • Nantes, France, 44093
    • Active, not recruiting
    • CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
  • Nice, France, 06189
    • Active, not recruiting
    • Centre Antoine Lacassagne;B4 Hematologie Cancerologie
  • Nimes, France, 30029
    • Active, not recruiting
    • CHU de Nîmes - Hôpital Caremeau
  • Paris, France, 75571
    • Active, not recruiting
    • Hopital Saint Antoine; Hematologie Clinique
  • Paris, France, 75475
    • Active, not recruiting
    • Hôpital Saint-Louis; Service d'Hématologie
  • Pessac, France, 33604
    • Active, not recruiting
    • Hopital De Haut Leveque; Hematologie Clinique
  • Pierre Benite, France, 69495
    • Active, not recruiting
    • Ch Lyon Sud; Hemato Secteur Jules Courmont
  • Poitiers, France, 86021
    • Active, not recruiting
    • Hopital De La Miletrie; Hematologie Et Oncologie Medicale
  • Reims, France, 51100
    • Active, not recruiting
    • CHU de Reims
  • Rennes, France, 35033
    • Active, not recruiting
    • CHU Pontchaillou
  • Rouen, France, 76038
    • Active, not recruiting
    • Centre Henri Becquerel; Service Hématologie
  • St Priest En Jarez, France, 42271
    • Withdrawn
    • ICLN;Hopital De Jour Rdc
  • Strasbourg, France, 67200
    • Active, not recruiting
    • ICANS
• Germany
  • Augsburg, Germany, 86156
    • Withdrawn
    • Universitätsklinikum Augsburg; II. Med. Klinik
  • Bamberg, Germany, 96049
    • Withdrawn
    • Sozialstiftung Bamberg - Klinikum am Bruderwald, Med. Klinik V; Hämatologie und intern. Onkologie
  • Berlin, Germany, 10967
    • Active, not recruiting
    • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
  • Berlin, Germany, 12200
    • Active, not recruiting
    • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
  • Chemnitz, Germany, 09113
    • Withdrawn
    • Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie
  • Dresden, Germany, 01307
    • Active, not recruiting
    • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
  • Düsseldorf, Germany, 40479
    • Withdrawn
    • Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin
  • Giessen, Germany, 35392
    • Withdrawn
    • Medizinische Klinik IV, Hämatologie Universitätsklinikum Gießen
  • Halle (Saale), Germany, 06120
    • Active, not recruiting
    • Universitätsklinikum Halle; Klinik für Innere Medizin IV; Hämatologie und Onkologie
  • Heidelberg, Germany, 69120
    • Active, not recruiting
    • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
  • Homburg/Saar, Germany, 64421
    • Withdrawn
    • Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
  • Kaiserslautern, Germany, 67655
    • Withdrawn
    • Westpfalz-Klinikum GmbH; Innere Medizin 1, Hämatologie und internistischen Onkologie
  • Kiel, Germany, 24105
    • Withdrawn
    • Uni-Klinikum-Schleswig-Holstein; Klinik für Innere Medizin II; Hämatologie und Onkologie
  • Luebeck, Germany, 23538
    • Withdrawn
    • Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie
  • München, Germany, 81377
    • Withdrawn
    • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
  • Regensburg, Germany, 93053
    • Active, not recruiting
    • Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg
  • Rostock, Germany, 18057
    • Recruiting
    • Universitätsklinik Rostock; Klinik für Innere Med. III, Abteilung Hämatologie/Onkologie
  • Ulm, Germany, 89081
    • Completed
    • Universtitätsklinikum Ulm; Klinik für Innere Medizin III
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Active, not recruiting
      • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
    • Ravenna, Emilia-Romagna, Italy, 48121
      • Active, not recruiting
      • U.O. Ematologia AUSL Ravenna
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Completed
      • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
    • Varese, Lombardia, Italy, 21100
      • Withdrawn
      • Ospedale Di Circolo E Fondazione Macchi; Ematologia
  • Marche
    • Ancona, Marche, Italy, 60100
      • Active, not recruiting
      • Ospedali Riuniti Umberto I; Clinica di Ematologia
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Withdrawn
      • Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
  • Sicilia
    • Palermo, Sicilia, Italy, 90146
      • Active, not recruiting
      • Ospedale V. Cervello; U.O. Ematologia E Trapianti
  • Toscana
    • Florence, Toscana, Italy, 50134
      • Active, not recruiting
      • Azienda Ospedaliera Universitaria Careggi
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Active, not recruiting
      • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
• Japan
  • Aichi, Japan, 464-8681
    • Active, not recruiting
    • Aichi Cancer Center
  • Chiba, Japan, 277-8577
    • Active, not recruiting
    • National Cancer Center Hospital East
  • Hokkaido, Japan, 060-8648
    • Withdrawn
    • Hokkaido University Hospital
  • Kumamoto, Japan, 860-8556
    • Withdrawn
    • Kumamoto University Hospital
  • Kyoto, Japan, 602-8566
    • Active, not recruiting
    • University Hospital Kyoto Prefectural University of Medicine
  • Mie, Japan, 514-8507
    • Active, not recruiting
    • Mie University Hospital
  • Miyagi, Japan, 980-8574
    • Active, not recruiting
    • Tohoku University Hospital
  • Okayama, Japan, 700-8558
    • Active, not recruiting
    • Okayama University Hospital
  • Osaka, Japan, 545-8586
    • Withdrawn
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 589-8511
    • Withdrawn
    • Kindai University Hospital
  • Tokyo, Japan, 104-0045
    • Active, not recruiting
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • Active, not recruiting
    • The Cancer Institute Hospital of JFCR
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Active, not recruiting
    • Pusan National University Hospital
  • Seongnam-si, Korea, Republic of, 463-707
    • Active, not recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03722
    • Active, not recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Active, not recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • Seoul St Mary's Hospital
  • Seoul, Korea, Republic of, 03080
    • Completed
    • Seoul National University Hospital
• Poland
  • Gdansk, Poland
    • Active, not recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81-519
    • Active, not recruiting
    • Szpitale Pomorskie Sp. z o. o.; Oddzia? Hematologii i Transplantologii Szpiku
  • Katowice, Poland, 40-519
    • Active, not recruiting
    • Pratia Onkologia Katowice
  • Olsztyn, Poland, 10-228
    • Completed
    • Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Pozna?, Poland, 60-569
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
  • Warszawa, Poland, 02-776
    • Active, not recruiting
    • Instytut Hematologii i Transfuzjologii; Klinika Hematologii
  • Wroc?aw, Poland, 50-367
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
• Russian Federation
  • Penza, Russian Federation, 440071
    • Active, not recruiting
    • Penza Regional Oncology Dispensary
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Withdrawn
      • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
    • Moscow, Moskovskaja Oblast, Russian Federation, 125284
      • Active, not recruiting
      • City Clinical Botkin's Hospital; City Hematological Center
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603126
      • Withdrawn
      • Regional Clinical Hospital N.A. Semashko; Hematology
• Spain
  • Guipuzcoa, Spain, 20014
    • Active, not recruiting
    • Hospital de Donostia; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Hospital Universitario la Paz; Servicio de Hematologia
  • Murcia, Spain, 30008
    • Active, not recruiting
    • Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
  • Sevilla, Spain, 41013
    • Active, not recruiting
    • Hospital Universitario Virgen del Rocio; Servicio de Hematologia
  • Valencia, Spain, 46010
    • Active, not recruiting
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
• Taiwan
  • Kaoisung, Taiwan, 833
    • Active, not recruiting
    • Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
  • Taipei, Taiwan, 100
    • Active, not recruiting
    • National Taiwan Universtiy Hospital; Division of Hematology
  • Taipei City, Taiwan, 112
    • Active, not recruiting
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Active, not recruiting
    • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
• Turkey
  • ?eh?tkam?l, Turkey, 27090
    • Withdrawn
    • Sanko University Faculty of Medicine
  • Ankara, Turkey, 06010
    • Recruiting
    • Gulhane Training and Research Hospital
  • Ankara, Turkey, 06100
    • Active, not recruiting
    • Hacettepe Uni Medical Faculty; Hematology
  • Istanbul, Turkey, 34303
    • Active, not recruiting
    • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
  • Istanbul, Turkey
    • Completed
    • Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
  • Kayseri, Turkey, 38039
    • Withdrawn
    • Erciyes Uni ; Hematology
  • Sariyer, Turkey, 34450
    • Active, not recruiting
    • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
  • Trabzon, Turkey, 61800
    • Completed
    • Karadeniz Technical Uni School of Medicine; Hematology
• Ukraine
  • Kiev, Ukraine, 03115
    • Withdrawn
    • SIResearch Centre for Radiation Medicine of AMS of Ukraine; Department of Radiation Oncohematology
  • Kyiv, Ukraine, 03022
    • Withdrawn
    • National Institute of Cancer
  • KIEV Governorate
    • Kapitanivka, KIEV Governorate, Ukraine, 08111
      • Withdrawn
      • Medical Center named after academician Yuri Prokopovich Spizhenko; Oncochemotherpy Department
    • Mykolaiv, KIEV Governorate, Ukraine, 54058
      • Withdrawn
      • Mykolayiv Regional Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61070
      • Withdrawn
      • Municipal Noncommercial Institution Regional Center of Oncology
    • Zaporizhzhia, Kharkiv Governorate, Ukraine, 69600
      • Withdrawn
      • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
• United Kingdom
  • Cornwall, United Kingdom, TR1 3LJ
    • Completed
    • Royal Cornwall Hospitals NHS Trust
  • Gloucester, United Kingdom, GL1 3NN
    • Active, not recruiting
    • Gloucestershire Royal Hospital; Haematology Department
  • London, United Kingdom, SW3 6JJ
    • Active, not recruiting
    • Royal Marsden Hospital - Fulham
  • London, United Kingdom, W12 0HS
    • Active, not recruiting
    • Hammersmith Hospital; Dept of Oncology
  • Nottingham, United Kingdom, NG5 1PB
    • Active, not recruiting
    • Nottingham City Hospital; Dept of Haematology
  • Sutton, United Kingdom, SM2 5PT
    • Withdrawn
    • Royal Marsden Hospital; Dept of Medical Oncology
  • Torquay, United Kingdom, TQ2 7AA
    • Active, not recruiting
    • Torbay Hospital; Oncology
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Comprehensive Cancer Center
    • Encinitas, California, United States, 92024
      • Withdrawn
      • cCare
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Winship Cancer Institute
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology, Inc
    • Noblesville, Indiana, United States, 46062
      • Recruiting
      • Investigative Clinical Research Of Indiana, Llc
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Active, not recruiting
      • Johns Hopkins Uni ; Sidney Kimmel Comprehensive Care Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Active, not recruiting
      • University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Cancer & Hematology Center of West Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University; Wash Uni. Sch. Of Med
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • MD Anderson Cancer Center at Cooper
  • New York
    • Mineola, New York, United States, 11501
      • Recruiting
      • NYU Long Island Hospital
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Ambulatory Care Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Univ Health Svcs; Section on Hem and Onc
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center; Baylor Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
  • Washington
    • Kennewick, Washington, United States, 99336-7774
      • Recruiting
      • Kadlec Clinic Hematology and Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Histologically documented CD20+ FL (Grades 1-3a)
• Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires criteria
• Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
• Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL. Pretreatment sample of at least 1 core-needle, excisional or incisional tumor biopsy is required. Cytological or fine-needle aspiration samples are not acceptable. Fresh pretreatment biopsy is preferred. Patients who are unable to undergo biopsy procedures may be eligible for study enrollment if an archival tumor tissue sample (preferably from the most recent relapse/persistence) as paraffin blocks or at least 15 unstained slides, or in accordance with local regulatory requirements, can be sent to the Sponsor.
• Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
• Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program.
• For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception, including at least 1 method with a failure rate of < 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after final dose of rituximab. Women must refrain from donating eggs during this same period.
• For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 28 days after last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

• Grade 3b FL
• History of transformation of indolent disease to diffuse-large B cell lymphoma
• Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
• Active or history of CNS lymphoma or leptomeningeal infiltration
• Prior standard or investigational anti-cancer therapy as specified: Lenalidomide exposure within 12 months prior to Day 1 of Cycle 1; Chimeric antigen receptor T cell therapy within 30 days prior to Day 1 of Cycle 1; Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Cycle 1 Day 1; Treatment with any anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
• Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade </= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) prior to Day 1 of Cycle 1
• Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
• History of solid organ transplantation
• History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies
• Known sensitivity or allergy to murine products
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including mannitol
• History of erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
• History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
• Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
• Known or suspected chronic active Epstein-Barr virus (EBV) infection
• Known or suspected history of hemophagocytic lymphohistiocytosis
• Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
• Active Hepatitis B infection
• Active Hepatitis C infection
• Known history of HIV positive status
• History of progressive multifocal leukoencephalopathy (PML)
• Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
• Other malignancy that could affect compliance with the protocol or interpretation of results
• Active autoimmune disease requiring treatment
• History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• Prior allogeneic stem cell transplantation
• Contraindication to treatment for thromboembolism prophylaxis
• Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
• Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
• Pregnant or lactating or intending to become pregnant during the study
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M + Len (Arm A); Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)	Drug: Mosunetuzumab; Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12; Drug: Lenalidomide; Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len); Drug: Tociluzumab; Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
Experimental: R + Len (Arm B); Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)	Drug: Lenalidomide; Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len); Drug: Tociluzumab; Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events; Drug: Rituximab; Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11
Experimental: M + Len (US Extension Arm C); Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)	Drug: Mosunetuzumab; Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12; Drug: Lenalidomide; Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len); Drug: Tociluzumab; Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS) according to 2014 Lugano Response Criteria	From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
PFS as Determined by the Investigator	From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8 years)
Complete Response Rate	Up to approximately 8 years
Objective Response Rate (ORR)	Up to approximately 8 years
Overall Survival (OS)	From randomization to death from any cause (up to approximately 8 years)
Duration of Objective Response (DOR)	From the first occurrence of a documented objective response (complete response or partial response) to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)
Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)	Up to approximately 8 years
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)	Up to approximately 8 years
Percentage of Participants with Adverse Events (AEs)	Up to approximately 8 years
Serum Concentration of M + Len	Up to approximately 8 years
Area Under the Curve (AUC) of M + Len	Up to approximately 8 years
Percentage of Participants with Anti-Drug Antibodies (ADAs)	Up to approximately 8 years
Time to Next Anti-Lymphoma Treatment (TTNALT)	From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8 years)
Duration of Complete Reponse (DOCR)	From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): August 25, 2025
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide; Rituximab
• Other Study ID Numbers: GO42909; 2020-005239-53 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No