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Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL
Sponsor: Ou Bai, MD/PHD
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
Conditions
Interventions
Chidamide
Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.
Rituximab
Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.
Cyclophosphamide
Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.
Doxorubicin
Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.
Vincristine
Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.
Prednisone
Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.
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