NCT04980222

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-22
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2021-07-28
• Last updated: 2026-02-17

Locations

18 sites across 6 countries: United States, Denmark, France, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study