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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
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
Conditions
Interventions
Mosunetuzumab (IV)
Participants will receive intravenous (IV) mosunetuzumab.
Mosunetuzumab (SC)
Participants will receive subcutaneous (SC) mosunetuzumab.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin.
Tocilizumab
Participants will receive IV tocilizumab as needed.
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