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A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

NCT05364424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-12-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab for up to 3 cycles.

DRUG

Obinutuzumab

Participants will receive IV obinutuzumab on Cycle 1 Day 1.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.

DRUG

Rituximab

Participants will receive up to 2 doses of IV rituximab.

DRUG

Ifosfamide

Participants will receive IV ifosfamide for up to 3 cycles.

DRUG

Carboplatin

Participants will receive IV carboplatin for up to 3 cycles.

DRUG

Etoposide

Participants will receive IV etoposide for up to 3 cycles.

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
2022-11-04
Primary Completion
2025-10-15
Completion
2025-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT05364424 on ClinicalTrials.gov