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A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Large B-Cell Lymphoma

NCT07599423 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).

Conditions

Interventions

DRUG

Obinutuzumab

A single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS).

DRUG

Glofitamab

Glofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS: Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity.

DRUG

Gemcitabine

Administered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

DRUG

Oxaliplatin

Administered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

DRUG

Salvage Chemotherapy (Investigator's Choice)

Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R .

DRUG

Autologous Stem Cell Transplantation (ASCT)

Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2030-06-01
Completion
2030-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT07599423 on ClinicalTrials.gov