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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

NCT06047080 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1130

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2027-10-01
Completion
2030-10-30
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047080 on ClinicalTrials.gov