NCT04712097Active, not recruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 478 (actual)
- First submitted
- 13 Jan 2021
- Start date
- 27 Oct 2021
- Primary completion date
- 3 Jun 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Follicular lymphoma
- NCT number
- NCT04712097
- EU CT number
- 2023-505807-21-00
- EudraCT number
- 2020-005239-53
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 478
- From 27 Oct 2021 to the primary completion date, 3 Jun 2026
- 110 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
- 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 erythema multiforme, Grade \>/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
- 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
- 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
- Prior allogeneic stem cell transplantation
- 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
Other illness
- Any history of disease transformation and/or diffuse-large B cell lymphoma (DLBCL)
- Active or history of CNS lymphoma or leptomeningeal infiltration
- 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 interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
- 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)
- 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
- Contraindication to treatment for thromboembolism prophylaxis
Lab values
- 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
Other
- Grade 3b FL
- Pregnant or lactating or intending to become pregnant during the study
Who the study is looking for
- 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 (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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (110)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Geelong Hospital Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Princess Alexandra Hospital Woolloongabba Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Ictrials Pesquisa e Desenvolvimento Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital das Clinicas - UFRGS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Alemão Oswaldo Cruz Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Cancer Center, Sun Yat-sen University of Medical Sciences Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The 1st Affiliated Hospital of Nanchang Unversity Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Active, not recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Active, not recruiting |
| Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 05 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Pessac Cedex | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Royal Cornwall Hospitals NHS Trust Coordinator of this site? Confirm its status | Cornwall | United Kingdom | Unknown status |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Torbay Hospital Coordinator of this site? Confirm its status | Torquay | United Kingdom | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Active, not recruiting |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Mie University Hospital Coordinator of this site? Confirm its status | Mie | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| City Clinical Botkin's Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Penza Regional Oncology Dispensary Coordinator of this site? Confirm its status | Penza | Russia | Unknown status |
| Chang Gung Medical Foundation - Kaohsiung;Oncology Coordinator of this site? Confirm its status | Kaoisung | Taiwan | Unknown status |
| National Taiwan Universtiy Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation - Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| University of Michigan Health System Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins Uni Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Cancer & Hematology Center of West Michigan Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Kadlec Clinic Hematology and Oncology Coordinator of this site? Confirm its status | Kennewick | United States | Unknown status |
| NYU Long Island Hospital Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| NYU Langone Ambulatory Care Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Investigative Clinical Research of Indiana, LLC Coordinator of this site? Confirm its status | Noblesville | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center- Montefiore Medical Park Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Wake Forest Univ Health Svcs Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Hacettepe Uni Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes? Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Atakent Acibadem Private Hosptial Halkali Merkez Mh., Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine) Coordinator of this site? Confirm its status | Sariyer | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.