Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
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
Study ID: NCT03671018
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Brussel, , 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, Caceres, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Infanta Leonor; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Plymouth Hospitals NHS Trust; Pharmacy Dept, Plymouth, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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