NCT06570447

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Detailed description

This is an open-label, single-arm, single-center study to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in the patient ≥ 18 years of age with recurrent/refractory diffuse large B-cell lymphoma. Subjects who meet the eligibility criteria will receive combination therapy of Glofitamab, chidamide. The study will include the following sequential phases: screening, treatment, and follow-up.

Conditions

• Diffuse Large B-Cell Lymphoma-Recurrent
• Diffuse Large B-Cell Lymphoma-Refractory

Interventions

Type	Name	Description
DRUG	Glofitamab	For Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.
DRUG	Chidamide	Chidamide: 30 mg/d orally twice a week for 21 days as a treatment cycle.

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-08-26
• Last updated: 2025-03-13

Locations

1 site across 1 country: China