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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
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
Glofitamab
Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.
Tocilizumab
Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
Doxorubicin
Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.
Vincristine
Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.
Prednisone
Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.
Rituximab
Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.
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