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A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

NCT04980222 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-02-17

No results posted yet for this study

Summary

This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.

Conditions

Interventions

DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab as per schedule specified in the treatment arm.

DRUG

Tocilizumab

Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

DRUG

Doxorubicin

Participants will receive 50 mg/m2 body surface area of doxorubicin IV as per schedule specified in the treatment arm.

DRUG

Vincristine

Participants will receive 1.4 mg/m2 body surface area of vincristine IV as per schedule specified in the treatment arm.

DRUG

Prednisone

Participants will receive 100 mg of prednisone or prednisolone as per schedule specified in the treatment arm.

DRUG

Rituximab

Participants will receive 375 mg/m2 body surface area of rituximab IV as per schedule specified in the treatment arm.

DRUG

Cyclophosphamide

Participants will receive 750 mg/m2 body surface area of cyclophosphamide IV as per schedule specified in the treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Netherlands
  • Poland
  • Spain

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 NCT04980222 on ClinicalTrials.gov