NCT04980222View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 22, 2022

Primary Completion Date

October 24, 2024

Study Completion Date

September 30, 2026

Conditions
Lymphoma
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.

Trial Locations (23)

8200

Aarhus Universitetshospital Skejby, Aarhus N

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Cancer Center at Westchester, Harrison

11553

Memorial Sloan Kettering Cancer Center at Nassau, Uniondale

11725

Memorial Sloan-Kettering; Cancer Center, Commack

28007

Hospital General Universitario Gregorio Marañon, Madrid

28041

Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid

37007

Hospital Clinico Universitario de Salamanca, Salamanca

52242

University of Iowa, Iowa City

63110

Washington University; Wash Uni. Sch. Of Med, St Louis

75204

Baylor University Medical Center, Dallas

76038

Centre Henri Becquerel, Rouen

91010

City of Hope Comprehensive Cancer Center, Duarte

94010

Hopital Henri Mondor, Créteil

94305

Stanford Cancer Institute Inpatient Investigational Pharmacy, Stanford

94305-5820

Stanford Cancer Center, Stanford

07920

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering - Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

80-211

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii, Gda?sk

50-367

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

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY