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ACTIVE NOT RECRUITING
NCT04712097
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

478

Start Date

2021-10-27

Completion Date

2029-12-31

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

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

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

DRUG

Tociluzumab

Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events

Locations (112)

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

Padova, 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)

Yellowplace, 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