NCT07480850

Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma

Efficacy and Safety of Glofitamab Combined With GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.

Detailed description

Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.

Conditions

• Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Glofitamab	On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUG	Gemcitabin	On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUG	Oxaliplatin	On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUG	Obinutuzumab	On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-02
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: China