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Recruiting Phase 2 NCT06570447

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

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Trial Parameters

Condition Diffuse Large B-Cell Lymphoma-Recurrent
Sponsor Tianjin Medical University Cancer Institute and Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 22
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-15
Completion 2026-12-31
Interventions
GlofitamabChidamide

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Brief 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 Criteria

Inclusion Criteria: \- To be eligible for enrollment in this study, a subject must meet all of the following criteria: 1. Signed informed consent 2. Age ≥ 18 years at the time of informed consent 3. Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures. 4. Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL) \- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if perf

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