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)

May 4, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
478

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital Woolloongabba
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Geelong Hospital
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80510-130
        • ICTR Curitiba
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital das Clinicas - UFRGS
      • Porto Alegre, Rio Grande do Sul, Brazil, 90470-340
        • Hospital Mae de Deus
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01327-001
        • Hospital Alemao Oswaldo Cruz
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Guangzhou, China, 510060
        • Cancer Center, Sun Yat-sen University of Medical Sciences
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanchang, China, 330200
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nanjing, China, 210036
        • Jiangsu Province Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 301636
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
      • Wuhan, China, 430030
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, China, 430023
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
  • France
      • Bayonne, France, 64109
        • Centre Hospitalier de La Cote Basque
      • Chambéry, France, 73011
        • Ch De Chambery
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Montpellier, France, 34295
        • Chu Saint Eloi
      • Nantes, France, 44093
        • CHU Nantes - Hotel Dieu
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nîmes, France, 30029
        • CHU de Nîmes - Hôpital Carémeau
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Pessac, France, 33604
        • Hopital De Haut Leveque
      • Pierre-Bénite, France, 69495
        • CH Lyon Sud
      • Poitiers, France, 86021
        • Hôpital de la Milétrie
      • Reims, France, 51100
        • CHU de reims
      • Rennes, France, 35033
        • CHU Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Strasbourg, France, 67098
        • CHU de Strasbourg
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
      • Dresden, Germany, 01307
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf
      • Halle, Germany, 06120
        • Universitätsklinikum Halle
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
      • Regensburg, Germany, 93053
        • Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg
      • Rostock, Germany, 18057
        • Universitätsklinik Rostock
      • Ulm, Germany, 89081
        • Universtitätsklinikum Ulm
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • U.O. Ematologia AUSL Ravenna
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Ospedale V. Cervello
    • The Marches
      • Ancona, The Marches, Italy, 60100
        • Ospedali Riuniti Umberto I
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Mie, Japan, 514-8507
        • Mie University Hospital
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o. o.
      • Katowice, Poland, 41-500
        • Pratia Onkologia Katowice
      • Późna, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny W Poznaniu
      • Warsaw, Poland, 02-776
        • Instytut Hematologii I Transfuzjologii
      • Wroc?aw, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Russia
      • Moscow, Russia, 129110
        • City Clinical Botkin's Hospital
      • Penza, Russia, 440071
        • Penza Regional Oncology Dispensary
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Seongnam-si, South Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06591
        • Seoul St Mary's Hospital
      • Seoul, South Korea, (0)6351
        • Samsung Medical Center
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Murcia, Spain, 30008
        • Hospital General Universitario J.M Morales Meseguer
      • Seville, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Guipuzcoa
      • Guipuzcoa, Guipuzcoa, Spain, 20014
        • Hospital de Donostia
  • Taiwan
      • Kaoisung, Taiwan, 833
        • Chang Gung Medical Foundation - Kaohsiung;Oncology
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan Universtiy Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe Uni Medical Faculty
      • Istanbul, Turkey (Türkiye), 34303
        • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
      • Istanbul, Turkey (Türkiye)
        • Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
      • Yellowplace, Turkey (Türkiye), 34450
        • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
  • United Kingdom
      • Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospitals NHS Trust
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology, Inc
      • Noblesville, Indiana, United States, 46062
        • Investigative Clinical Research of Indiana, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Uni
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Center of West Michigan
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Mineola, New York, United States, 11501
        • NYU Long Island Hospital
      • New York, New York, United States, 10016
        • NYU Langone Ambulatory Care Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center - Montefiore Medical Park
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ Health Svcs
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Kennewick, Washington, United States, 99336-7774
        • Kadlec Clinic Hematology and Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression Free Survival (PFS) according to 2014 Lugano Response Criteria
Time Frame: 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 8.5 years)
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 8.5 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PFS as Determined by the Investigator
Time Frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8.5 years)
From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8.5 years)
Complete Response Rate
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to approximately 8.5 years)
From randomization to death from any cause (up to approximately 8.5 years)
Duration of Objective Response (DOR)
Time Frame: 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 8.5 years)
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 8.5 years)
Duration of Complete Reponse (DOCR)
Time Frame: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 years)
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 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)
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Serum Concentration of M + Len
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Area Under the Curve (AUC) of M + Len
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 8.5 years
Up to approximately 8.5 years
Time to New Anti-Lymphoma Treatment (TTNALT)
Time Frame: From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8.5 years)
From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO42909
  • 2020-005239-53 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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