Actively Recruiting
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP
Led by Ou Bai, MD/PHD · Updated on 2026-03-25
200
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- No prior treatment for DLBCL except R-CHOP chemotherapy and specific biopsy or surgery
- Complete response after 6 cycles of R-CHOP confirmed by imaging and clinical assessment
- Histopathological diagnosis of CD20-positive DLBCL and positive hepatitis B infection with stable antiviral therapy for at least 4 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Laboratory values within specified ranges for hemoglobin, neutrophils, platelets, creatinine, bilirubin, ALT, and AST
- Life expectancy of at least 6 months
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women, or those unwilling to use contraception
- History of significant heart conditions including QTc prolongation, ventricular tachycardia, atrial fibrillation, heart block, recent myocardial infarction, congestive heart failure, or coronary artery disease requiring medication
- Prior organ transplantation
- Treatment for myelotoxicity within 7 days before enrollment
- Active bleeding
- History or current thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or related conditions
- Active infection or persistent fever within 14 days before enrollment
- Incomplete recovery from major organ surgery within 6 weeks
- Abnormal liver or kidney function beyond specified limits
- Mental disorders or inability to provide informed consent
- Drug abuse or chronic alcoholism interfering with evaluation
- Lymphoma involving the central nervous system
- Any condition judged by the investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
O
Ou Bai, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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