RecruitingPhase 2NCT07493148

Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL

A Phase II, Open-label, Single-arm Clinical Study of Chidamide in Combination With the R-mini CHOP Regimen, Followed by Chidamide Plus CD20 as Maintenance Therapy, in Elderly Patients With Newly Diagnosed MYC/BCL2 Co-expressor DLBCL


Sponsor

Ou Bai, MD/PHD

Enrollment

50 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chidamide, a drug called Chidamide + Rituximab maintenance, and others for people with diffuse large b-cell lymphoma (dlbcl). The study is currently recruiting participants at 1 location. People eligible for this study include aged 70 Years and older.

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

DRUGChidamide

Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.

DRUGRituximab

Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.

DRUGCyclophosphamide

Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.

DRUGDoxorubicin

Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.

DRUGVincristine

Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.

DRUGPrednisone

Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.

DRUGChidamide + Rituximab maintenance

Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg/m² IV, once every 12 weeks. 21 days/cycle.


Locations(1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

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NCT07493148


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