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Brief Title: A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma
Study ID: NCT03677141
Brief Summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama Birmingham, Birmingham, Alabama, United States
University of California; Moores Cancer Center, La Jolla, California, United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica, Santa Monica, California, United States
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Scott and White Hospital; Cancer Center, Temple, Texas, United States
Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU, Salzburg, , Austria
LKH Steyr, Steyr, , Austria
Medizinische Universit盲t Wien, Allgemeines Krankenhaus der Stadt Wien, Wien, , Austria
Hanusch-Krankenhaus, Wien, , Austria
CHU Henri Mondor; Service d'Oncologie Medicale, Creteil, , France
Centre Leon Berard, Lyon, , France
H么pital Saint-Louis, Paris, , France
Centre Henri Becquerel- Centre de Lutte Contre le Cancer, Saint Herblain, , France
Gustave Roussy, Villejuif, , France
Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Maria Sklodowska-Curie Memorial Cancer Centre, Gliwice, , Poland
Ma?opolskie Centrum Medyczne, Krak贸w, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Slupsk, , Poland
Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chor贸b Wewn?trznych, Warsaw, , Poland
Katedra i Klinika Hematologii; Nowotwor贸w Krwi i Transplantacji Szpiku, Wroc?aw, , Poland
Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Virgen Macarena, Seville, Sevilla, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital San Pedro de Alcantara; Servicio de Hematolog铆a, Caceres, , Spain
Hospital General Universitario Gregorio Mara帽on, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR