NCT06047080

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,130 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Conditions

• Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Glofitamab	Participants will receive intravenous (IV) glofitamab
DRUG	Polatuzumab vedotin	Participants will receive IV polatuzumab vedotin in combination with R-CHP
DRUG	Rituximab	Participants will receive IV rituximab
DRUG	Cyclophosphamide	Participants will receive cyclophosphamide as part of CHP chemotherapy
DRUG	Doxorubicin	Participants will receive IV doxorubicin
DRUG	Prednisone	Participants will receive oral prednisone as part of CHP chemotherapy

Timeline

• Start date: 2023-09-18
• Primary completion: 2027-10-01
• Completion: 2030-10-30
• First posted: 2023-09-21
• Last updated: 2026-03-18

Locations

229 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study