NCT07493148

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ou Bai, MD/PHD · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary study objective is to evaluate the 2-year progression-free survival (PFS) rate of chidamide in combination with the R-miniCHOP regimen. Secondary objectives include the objective response rate (ORR), duration of response (DOR), complete response (CR) rate, the percentage of patients converting from PR/SD to CR/PR, overall survival (OS), and safety parameters. The exploratory objective is to investigate the correlation between biomarkers (e.g., tumor genomics, proteomics) and ctDNA with treatment efficacy.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China