West Cancer Center

LYMPHOMA: DLBCL: 1st Line: CD20+: GO44145

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

Title

Roche GO44145 DLBCL 1st line

Study Title

Site Link

NCT06047080

Malignancy

DLBCL, lymphoma, diffuse large B cell lymphoma

Stage

Stage 4

Disease Setting

Primary lymphoma

Line Of Therapy

1st Line

Investigational Agent

Glofitimab

Drug Class

Anti-CD20 bispecific mAb

Jason Chandler, MD

Sponsor

Hoffmann La-Roche

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Previously untreated participants with CD20-positive LBCL
IPI score 2-5
ECOG PS 0-2
Measurable disease
EF >50%
HIV negative
No contraindications to Pola-R-CHP
No other history of lymphoma

Objective

Primary
- PFS
Secondary
- Event free survival efficacy
- CR rate
- ORR
- OS
- DoR
- DoCR
- DFS
- PK
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

CD20 positive DLBCL

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes