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ACTIVE NOT RECRUITING
NCT04980222
PHASE2

A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.

Official title: A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2022-03-22

Completion Date

2026-09-30

Last Updated

2026-02-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.

DRUG

Tocilizumab

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

DRUG

Doxorubicin

Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.

DRUG

Vincristine

Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.

DRUG

Prednisone

Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.

DRUG

Rituximab

Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.

DRUG

Cyclophosphamide

Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.

Locations (18)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Stanford Cancer Center

Stanford, California, United States

University of Iowa

Iowa City, Iowa, United States

Washington University; Wash Uni. Sch. Of Med

St Louis, Missouri, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Baylor University Medical Center

Dallas, Texas, United States

Aarhus Universitetshospital Skejby

Aarhus N, Denmark

Hopital Henri Mondor

Créteil, France

Centre Henri Becquerel

Rouen, France

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

Gdansk, Poland

Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

Wroclaw, Poland

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Univ. 12 de Octubre; Servicio de Hematologia

Madrid, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain