drugset / Trial / 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

NCT04980222

Phase 2 Active not recruiting 46 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-22
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Glofitamab Monoclonal antibody 30 mg Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Tocilizumab Monoclonal antibody
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications