A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
Running, not enrolling · Phase 1/Phase 2
Conditions studied: B-cell Non-Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03671018
- Run by
- Hoffmann-La Roche
- People needed
- 422
- Starts
- 2018-09-25
- Expected to finish
- 2025-07-20
- Last updated by the study team
- 2024-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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