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ACTIVE NOT RECRUITING
NCT04246086
PHASE1/PHASE2

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

Official title: A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

237

Start Date

2020-08-12

Completion Date

2030-09-06

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Mosunetuzumab (IV)

Participants will receive IV mosunetuzumab as defined by the study protocol

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol

DRUG

Lenalidomide

Participants will receive oral lenalidomide as defined by the study protocol

DRUG

Mosunetuzumab (SC)

Participants will receive SC mosunetuzumab as defined by the study protocol

Locations (26)

City of Hope National Medical Center

Duarte, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Norton Cancer Institute - St. Matthews

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Ctr

Baton Rouge, Louisiana, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hillcrest Hospital

Mayfield Heights, Ohio, United States

Rhode Island Hematology/Oncology Program

Woonsocket, Rhode Island, United States

Tennessee Oncology;Chattanooga Oncology & Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology PLLC - Franklin

Franklin, Tennessee, United States

Swedish Medical Center

Seattle, Washington, United States

The First Hospital of Jilin University

Changchun, China

West China Hospital, Sichuan University

Chengdu, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjing, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

University College London Hospitals NHS Foundation Trust - University College Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, United Kingdom