Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for lymphoma patients: drug duo aims to control relapsed disease

NCT ID NCT04712097

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether a new combination of drugs (mosunetuzumab plus lenalidomide) works better than the current standard (rituximab plus lenalidomide) for people with follicular lymphoma that has returned after at least one prior treatment. About 478 participants will receive either the new or standard combo, and researchers will track how long the cancer stays under control. The goal is to improve outcomes without increasing serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mosunetuzumab and lenalidomide
What this could lead to
If successful, this combination could offer a more effective treatment option for people with follicular lymphoma that has returned or not responded to prior therapy.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The new combination may not prove better than the standard treatment, and side effects like cytokine release syndrome are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

478 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (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: * Grade 3b FL * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Relapsed or refractory follicular lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

follicular lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory follicular lymphoma

Contacts and locations

Locations

  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

    Bologna, Emilia-Romagna, 40138, Italy

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,

    Istanbul, 34303, Turkey (Türkiye)

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307, Germany

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU Saint Eloi

    Montpellier, 34295, France

  • CHU de Nîmes - Hôpital Carémeau

    Nîmes, 30029, France

  • CHU de Reims

    Reims, 51100, France

  • CHU de Strasbourg

    Strasbourg, 67098, France

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Cancer & Hematology Center of West Michigan

    Grand Rapids, Michigan, 49503, United States

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060, China

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64109, France

  • Ch De Chambery

    Chambéry, 73011, France

  • Ch Lyon Sud

    Pierre-Bénite, 69495, France

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaoisung, 833, Taiwan

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • City Clinical Botkin's Hospital

    Moscow, 129110, Russia

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

    Padova, Veneto, 35128, Italy

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN, United Kingdom

  • Hacettepe Uni Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital De Haut Leveque

    Pessac, 33604, France

  • Hopital De La Miletrie

    Poitiers, 86021, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Saint Antoine

    Paris, 75571, France

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001, Brazil

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008, Spain

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario la Paz

    Madrid, 28046, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Donostia

    Guipuzcoa, Guipuzcoa, 20014, Spain

  • Hôpital Saint-Louis

    Paris, 75475, France

  • ICTR Curitiba

    Curitiba, Paraná, 80510-130, Brazil

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, 301636, China

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Investigative Clinical Research of Indiana, LLC

    Noblesville, Indiana, 46062, United States

  • Jiangsu Province Hospital

    Nanjing, 210036, China

  • Johns Hopkins Uni

    Baltimore, Maryland, 21231, United States

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336-7774, United States

  • Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg

    Regensburg, 93053, Germany

  • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

    Sariyer, 34450, Turkey (Türkiye)

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?

    Istanbul, Turkey (Türkiye)

  • Mie University Hospital

    Mie, 514-8507, Japan

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10461, United States

  • NYU Langone Ambulatory Care Center

    New York, New York, 10016, United States

  • NYU Long Island Hospital

    Mineola, New York, 11501, United States

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Taiwan Universtiy Hospital

    Taipei, 100, Taiwan

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ospedale V. Cervello

    Palermo, Sicily, 90146, Italy

  • Ospedali Riuniti Umberto I

    Ancona, The Marches, 60100, Italy

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Penza Regional Oncology Dispensary

    Penza, 440071, Russia

  • Pratia Onkologia Katowice

    Katowice, 41-500, Poland

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland, 4102, Australia

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Cornwall Hospitals NHS Trust

    Cornwall, TR1 3LJ, United Kingdom

  • Samsung Medical Center

    Seoul, (0)6351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519, Poland

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330200, China

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Torbay Hospital

    Torquay, TQ2 7AA, United Kingdom

  • U.O. Ematologia AUSL Ravenna

    Ravenna, Emilia-Romagna, 48121, Italy

  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

    Heidelberg, 69120, Germany

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023, China

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinik Rostock

    Rostock, 18057, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

  • Universtitätsklinikum Ulm

    Ulm, 89081, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

    Berlin, 10967, Germany

  • Wake Forest Univ Health Svcs

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Zhejiang Cancer Hospital

    Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.