RecruitingPhase 2NCT06570447

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

22 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of glofitamab (an immune therapy that directs T-cells to attack lymphoma cells) with chidamide (an oral drug that makes cancer cells more vulnerable) in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — meaning the cancer came back or never fully responded to initial treatment. **You may be eligible if:** - You are 18 or older with confirmed DLBCL (including high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or follicular lymphoma that transformed to DLBCL) - Your lymphoma came back or did not respond to at least one prior treatment - You are willing to comply with hospitalization requirements following glofitamab doses - You have a pathology report from initial diagnosis available **You may NOT be eligible if:** - You have never been treated for DLBCL before (this study is for relapsed/refractory patients) - You have active or uncontrolled infection - You have other significant health conditions preventing study participation - Your general health is too poor to tolerate the treatment regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlofitamab

For Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.

DRUGChidamide

Chidamide: 30 mg/d orally twice a week for 21 days as a treatment cycle.


Locations(1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China

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NCT06570447


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