A Phase 3 interventional study of Glofitamab and Polatuzumab vedotin in Large B-Cell Lymphoma, sponsored by Hoffmann-La Roche. Active, not recruiting at 229 sites in 21 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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).
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
Drug: Glofitamab · Drug: Polatuzumab vedotin · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Prednisone
Participants will receive Pola-R-CHP.
Drug: Polatuzumab vedotin · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Prednisone
Participants will receive intravenous (IV) glofitamab
Participants will receive IV polatuzumab vedotin in combination with R-CHP
Participants will receive IV rituximab
Participants will receive cyclophosphamide as part of CHP chemotherapy
Participants will receive IV doxorubicin
Participants will receive oral prednisone as part of CHP chemotherapy
Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
Time frame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
PFS as determined by the investigator
Time frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)
PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5
Time frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)
Event-free survival efficacy causes (EFSeff)
Time frame: From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
Complete response (CR) rate
Time frame: At the end of treatment (up to approximately 65 months)
Objective response rate (ORR)
Time frame: At treatment completion or discontinuation (up to approximately 65 months)
Overall survival (OS)
Time frame: From randomization to death from any cause (up to approximately 65 months)
Duration of response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)
Duration of complete response (DOCR)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)
Disease-free survival (DFS)
Time frame: From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
Serum concentration of glofitamab
Time frame: Up to approximately 65 months
Incidence of anti-drug antibodies (ADAs)
Time frame: Baseline up to approximately 65 months
Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Time frame: Up to approximately 65 months
Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Time frame: Up to approximately 65 months
Percentage of Participants with Adverse Events (AEs)
Time frame: From randomization to the end of study (up to approximately 65 months)
Showing the first 100 of 229 sites across 21 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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