Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP
NCT07493109 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-03-25
Summary
To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.
Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
- DRUG
-
Chidamide
Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle.
- DRUG
-
Entecavir Tablets
Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)
Sponsors & Collaborators
-
Ou Bai, MD/PHD
lead OTHER
Principal Investigators
-
Ou Bai, PHD · The First Bethune Hospital of Jilin University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-30
- Primary Completion
- 2029-09-30
- Completion
- 2030-09-30
Countries
- China
Study Locations
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