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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
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
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
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