NCT06047080|Active Not RecruitingPhase 3DMCFDA Drug

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

Hoffmann-La Roche ClinicalTrials.gov

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1 other identifier

GO44145

Study Type

interventional

Target

1,130

Locations

21 countries

Sites

229

Timeline

RegisteredSep 2023

StartedSep 2023

CompletionOct 2030

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,130

participants targeted

Target at P75+ for phase_3

Timeline

55mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach

21 countries

229 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.1 years study duration

Study Progress37%

Sep 2023Oct 2030

First Submitted

Initial submission to the registry

September 14, 2023

Completed

4 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

September 14, 2023

Last Update Submit

March 16, 2026

Conditions

Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
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)

Secondary Outcomes (14)

PFS as determined by the investigator
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
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)
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
At the end of treatment (up to approximately 65 months)
Objective response rate (ORR)
At treatment completion or discontinuation (up to approximately 65 months)
+9 more secondary outcomes

Study Arms (2)

Glofitamab + Pola-R-CHP

EXPERIMENTAL

Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).

Drug: GlofitamabDrug: Polatuzumab vedotinDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: Prednisone

Pola-R-CHP

ACTIVE COMPARATOR

Participants will receive Pola-R-CHP.

Drug: Polatuzumab vedotinDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: Prednisone

Interventions

GlofitamabDRUG

Participants will receive intravenous (IV) glofitamab

Glofitamab + Pola-R-CHP

Polatuzumab vedotinDRUG

Participants will receive IV polatuzumab vedotin in combination with R-CHP