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A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Sponsor: The First Affiliated Hospital of Soochow University
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 diffuse large B-cell lymphoma (R/R DLBCL) 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).
Official title: An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-07-22
Completion Date
2030-12-31
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
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).
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.
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).
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).
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 .
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.
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China