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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

May 23, 2019

Primary Completion Date

August 7, 2025

Study Completion Date

August 7, 2025

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Mosunetuzumab Intravenous (IV)

Participants in cohorts A and B will receive IV mosunetuzumab.

DRUG

Mosunetuzumab Subcutaneous (SC)

Participants in Cohort C will receive SC mosunetuzumab.

DRUG

Polatuzumab Vedotin

Participants in Cohort C will receive IV polatuzumab vedotin.

DRUG

Tocilizumab

Participants will receive tocilizumab via IV as needed to manage severe cytokine release syndrome (CRS).

Trial Locations (32)

10002

National Taiwan University Hospital, Taipei

10003

Hospital San Pedro de Alcantara, Cáceres

19111

Fox Chase Cancer Center, Philadelphia

21201

University of Maryland Medical Center, Baltimore

28007

Hospital General Universitario Gregorio Marañon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

31096

Rambam Medical Center, Haifa

41071

Hospital Universitario Virgen Macarena, Seville

41931

Keimyung University Dongsan Hospital, Daegu

46805

Fort Wayne Medical Institute, Fort Wayne

49241

Pusan National University Hospital, Busan

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

91120

Hadassah Ein-Karem, Jerusalem

3436212

Carmel medical center, Haifa

4428164

Meir Medical Center, Kfar Saba

5262100

Sheba Medical Center, Ramat Gan

8410101

Soroka Medical Center, Beersheba

9103102

Shaare Zedek Medical Center, Jerusalem

352331912

University of Alabama at Birmingham School of Medicine, Birmingham

90404-2023

University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica, Santa Monica

27708-9963

Duke University, Durham

02903

Rhode Island Hospital, Providence

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

30-727

PRATIA MCM Kraków, Krakow

20-090

Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli, Lublin

45-372

Szpital Wojewodzki w Opolu, Opole

(0)6351

Samsung Medical Center, Seoul

(0)7345

The Catholic University of Korea Yeouido St. Mary's Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

08035

Hospital Universitario Vall d Hebron, Barcelona

08908

Institut Catala d Oncologia Hospitalet, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03677154 - 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 | Biotech Hunter | Biotech Hunter