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Brief Title: Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
Official Title: A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients With Diffuse Large B-Cell Lymphoma Following First-Line Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Study ID: NCT03677154
Brief Summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica, Santa Monica, California, United States
University of Miami Sylvester Comprehensive Center, Miami, Florida, United States
Miami Cancer Institute of Baptist Health, Inc., Miami, Florida, United States
Moffitt Cancer Center Screening and Prevention, Tampa, Florida, United States
Rush University Medical Center; Rush University Cancer Center, Chicago, Illinois, United States
Fort Wayne Medical Institute, Fort Wayne, Indiana, United States
Norton Medical Plaza II; Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Sloan Kettering Cancer Center, New York, New York, United States
Duke University, Durham, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Soroka Medical Center, Beer Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Carmel medical center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Ein-Karem; Clinical Pharmacology Unit, Jerusalem, , Israel
Meir Medical Center, Kfar- Saba, , Israel
Laniado Hospital-Sanz Medical Center, Netanya, , Israel
Rabin Medical Center-Beilinson Campus, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv, , Israel
Pusan National University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Szpitale Pomorskie Sp. z o. o., Gdynia, , Poland
PRATIA MCM Kraków, Kraków, , Poland
Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli, Lublin, , Poland
Szpital Wojewodzki w Opolu;Pododdz. Gastroenter., Pododdz. Hematologii, Opole, , Poland
Instytut Hematologii i Transfuzjologii; Klinika Hematologii, Warszawa, , Poland
Institut Catala d Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen Macarena, Seville, Sevilla, Spain
Hospital Universitario Vall d Hebron, Barcelona, , Spain
Hospital San Pedro de Alcantara; Servicio de Hematología, Caceres, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Taipei Medical University ?Shuang Ho Hospital, New Taipei City, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
Chi-Mei Hospital, Liouying, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR