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ACTIVE NOT RECRUITING
NCT03671018
PHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Official title: An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

422

Start Date

2018-09-25

Completion Date

2025-07-20

Last Updated

2024-11-29

Healthy Volunteers

No

Interventions

DRUG

Mosunetuzumab (IV)

Participants will receive intravenous (IV) mosunetuzumab.

DRUG

Mosunetuzumab (SC)

Participants will receive subcutaneous (SC) mosunetuzumab.

DRUG

Polatuzumab vedotin

Participants will receive IV polatuzumab vedotin.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed.

DRUG

Rituximab

Participants will receive IV rituximab.

Locations (29)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

New York University Langone Medical Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin, Froedtert Hospital;Nephrology Section

Milwaukee, Wisconsin, United States

UZ Brussel

Brussels, Belgium

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, Belgium

Clinique St Pierre asbl

Ottignies, Belgium

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)

Saskatoon, Saskatchewan, Canada

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, Spain

Hospital de San Pedro de Alcantara

Cáceres, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Infanta Leonor; Servicio de Hematologia

Madrid, Spain

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, Spain

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Plymouth Hospitals NHS Trust; Pharmacy Dept

Plymouth, United Kingdom