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RECRUITING
NCT07493148
PHASE2

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

Sponsor: Ou Bai, MD/PHD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-04-30

Completion Date

2029-12-30

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Chidamide

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

DRUG

Rituximab

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

DRUG

Cyclophosphamide

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

DRUG

Doxorubicin

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

DRUG

Vincristine

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

DRUG

Prednisone

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

DRUG

Chidamide + 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