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
NCT ID: NCT04712097
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
478 participants
INTERVENTIONAL
2021-10-27
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
Tociluzumab
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
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)
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
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
Tociluzumab
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
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)
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
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
Tociluzumab
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
Interventions
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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
Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
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
Tociluzumab
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
Eligibility Criteria
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Inclusion Criteria
* 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 (GELF) 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
* Any history of disease transformation and/or diffuse-large B cell lymphoma (DLBCL)
* 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 (NCI CTCAE), 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, United States
Johns Hopkins Uni
Baltimore, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Cancer & Hematology Center of West Michigan
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
NYU Long Island Hospital
Mineola, New York, United States
NYU Langone Ambulatory Care Center
New York, New York, United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Univ Health Svcs
Winston-Salem, North Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Geelong Hospital
Geelong, Victoria, Australia
ICTR Curitiba
Curitiba, Paraná, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Peking University First Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zhejiang Cancer Hospital
Zhejiang, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Centre Hospitalier de La Cote Basque
Bayonne, , France
Ch De Chambery
Chambéry, , France
Hopital Henri Mondor
Créteil, , France
Hopital Claude Huriez
Lille, , France
Institut Paoli Calmettes
Marseille, , France
CHU Saint Eloi
Montpellier, , France
CHU NANTES - Hôtel Dieu
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU de Nîmes - Hôpital Carémeau
Nîmes, , France
Hôpital Saint-Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital De Haut Leveque
Pessac, , France
Ch Lyon Sud
Pierre-Bénite, , France
Hopital De La Miletrie
Poitiers, , France
CHU de Reims
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
ICANS
Strasbourg, , France
Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
Berlin, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, , Germany
Universitätsklinikum Halle
Halle, , Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, , Germany
Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg
Regensburg, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Universtitätsklinikum Ulm
Ulm, , Germany
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy
U.O. Ematologia AUSL Ravenna
Ravenna, Emilia-Romagna, Italy
Ospedale V. Cervello
Palermo, Sicily, Italy
Ospedali Riuniti Umberto I
Ancona, The Marches, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
Padua, Veneto, Italy
Aichi Cancer Center
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
Tohoku University Hospital
Miyagi, , Japan
Okayama University Hospital
Okayama, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, , Poland
City Clinical Botkin's Hospital
Moscow, , Russia
Penza Regional Oncology Dispensary
Penza, , Russia
Pusan National University Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Hospital de Donostia
Guipuzcoa, Guipuzcoa, Spain
Hospital Universitario la Paz
Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer
Murcia, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Chang Gung Medical Foundation - Kaohsiung;Oncology
Kaoisung, , Taiwan
National Taiwan Universtiy Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Hacettepe Uni Medical Faculty
Ankara, , Turkey (Türkiye)
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
Istanbul, , Turkey (Türkiye)
Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
Istanbul, , Turkey (Türkiye)
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
Sarıyer, , Turkey (Türkiye)
Royal Cornwall Hospitals NHS Trust
Cornwall, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Countries
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Other Identifiers
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2020-005239-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO42909
Identifier Type: -
Identifier Source: org_study_id
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