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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

October 27, 2021

Primary Completion Date

January 12, 2026

Study Completion Date

December 31, 2029

Conditions
Relapsed or Refractory Follicular Lymphoma
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

Trial Locations (112)

100

National Taiwan Universtiy Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

833

Chang Gung Medical Foundation - Kaohsiung;Oncology, Kaoisung

2298

Calvary Mater Newcastle, Waratah

3220

Geelong Hospital, Geelong

4102

Princess Alexandra Hospital Woolloongabba, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

10016

NYU Langone Ambulatory Care Center, New York

10461

Montefiore Medical Center - Montefiore Medical Park, The Bronx

10467

Montefiore Medical Center, The Bronx

10967

Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie, Berlin

11501

NYU Long Island Hospital, Mineola

13009

Institut Paoli Calmettes, Marseille

13605

Seoul National University Bundang Hospital, Seongnam-si

18057

Universitätsklinik Rostock, Rostock

20014

Hospital de Donostia, Guipuzcoa

21231

Johns Hopkins Uni, Baltimore

27157

Wake Forest Univ Health Svcs, Winston-Salem

27710

Duke University Medical Center, Durham

28046

Hospital Universitario la Paz, Madrid

30008

Hospital General Universitario J.M Morales Meseguer, Murcia

30029

CHU de Nîmes - Hôpital Carémeau, Nîmes

30322

Winship Cancer Institute, Atlanta

33604

Hopital De Haut Leveque, Pessac

34295

CHU Saint Eloi, Montpellier

34303

Atakent Acibadem Private Hosptial Halkali Merkez Mh.,, Istanbul

34450

Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine), Sarıyer

35033

CHU Pontchaillou, Rennes

35128

Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova, Padua

40138

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

41013

Hospital Universitario Virgen del Rocio, Seville

44093

CHU NANTES - Hôtel Dieu, Nantes

46010

Hospital Clinico Universitario de Valencia, Valencia

46062

Investigative Clinical Research of Indiana, LLC, Noblesville

46804

Fort Wayne Medical Oncology and Hematology, Inc, Fort Wayne

48109

University of Michigan Health System, Ann Arbor

48121

U.O. Ematologia AUSL Ravenna, Ravenna

49241

Pusan National University Hospital, Busan

49503

Cancer & Hematology Center of West Michigan, Grand Rapids

50134

Azienda Ospedaliera Universitaria Careggi, Florence

51100

CHU de Reims, Reims

59037

Hopital Claude Huriez, Lille

60100

Ospedali Riuniti Umberto I, Ancona

63110

Washington University, St Louis

64109

Centre Hospitalier de La Cote Basque, Bayonne

67200

ICANS, Strasbourg

69120

Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V, Heidelberg

69495

Ch Lyon Sud, Pierre-Bénite

73011

Ch De Chambery, Chambéry

75246

Baylor University Medical Center, Dallas

75475

Hôpital Saint-Louis, Paris

75571

Hopital Saint Antoine, Paris

76038

Centre Henri Becquerel, Rouen

77030

MD Anderson Cancer Center, Houston

86021

Hopital De La Miletrie, Poitiers

89081

Universtitätsklinikum Ulm, Ulm

90146

Ospedale V. Cervello, Palermo

91010

City of Hope Comprehensive Cancer Center, Duarte

93053

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

94010

Hopital Henri Mondor, Créteil

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

100191

Peking University Third Hospital, Beijing

129110

City Clinical Botkin's Hospital, Moscow

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Fudan University Shanghai Cancer Center, Shanghai

210036

Jiangsu Province Hospital, Nanjing

301636

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin

310022

Zhejiang Cancer Hospital, Zhejiang

330200

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

361003

The First Affiliated Hospital of Xiamen University, Xiamen

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

430030

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

440071

Penza Regional Oncology Dispensary, Penza

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510060

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

99336-7774

Kadlec Clinic Hematology and Oncology, Kennewick

80510-130

ICTR Curitiba, Curitiba

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

90470-340

Hospital Mae de Deus, Porto Alegre

01327-001

Hospital Alemao Oswaldo Cruz, São Paulo

06189

Centre Antoine Lacassagne, Nice

01307

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf, Dresden

06120

Universitätsklinikum Halle, Halle

464-8681

Aichi Cancer Center, Aichi

277-8577

National Cancer Center Hospital East, Chiba

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

514-8507

Mie University Hospital, Mie

980-8574

Tohoku University Hospital, Miyagi

700-8558

Okayama University Hospital, Okayama

104-0045

National Cancer Center Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

41-500

Pratia Onkologia Katowice, Katowice

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu, Późna

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroc?aw

(0)6351

Samsung Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06591

Seoul St Mary's Hospital, Seoul

06100

Hacettepe Uni Medical Faculty, Ankara

Unknown

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

TR1 3LJ

Royal Cornwall Hospitals NHS Trust, Cornwall

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

W12 0HS

Hammersmith Hospital, London

NG5 1PB

Nottingham City Hospital, Nottingham

TQ2 7AA

Torbay Hospital, Torquay

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY