Actively Recruiting
Evaluation of Chidamide for Maintenance Treatment of HBV-infected Diffuse Large B-Cell Lymphoma Following R-CHOP Therapy: A Prospective, Multicenter, Open-label Phase III Trial
Led by Ou Bai, MD/PHD · Updated on 2026-03-25
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of chidamide as a maintenance treatment for patients with diffuse large B-cell lymphoma (DLBCL) who also have hepatitis B virus (HBV) infection. These patients must have responded to initial treatment with R-CHOP chemotherapy. The goal is to provide clinical evidence for using chidamide in this specific patient group. This is a phase III, open-label, multicenter trial led by Ou Bai, MD/PhD. Participants are randomly assigned to one of two groups: the experimental group receiving chidamide or the control group receiving observation. Chidamide is given at 20 mg twice weekly on specified days within a 4-week cycle. All participants receive standardized antiviral drugs, such as Entecavir 0.5 mg daily, to manage HBV infection. The treatment cycles and antiviral therapy continue as part of the maintenance phase after initial chemotherapy. During the study, participants undergo regular assessments including imaging scans and lab tests to monitor disease progression and overall health. The main measure of success is progression-free survival at 2 years. Researchers also evaluate overall survival, safety, and biomarkers. Participants are monitored for side effects and treatment response over the trial period, which lasts until September 2030.
CONDITIONS
Brief 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 for 6 cycles of R-CHOP chemotherapy with complete response confirmed by imaging and clinical assessment
- Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) that is CD20-positive
- Positive hepatitis B infection defined by HBsAg positive, HBV DNA >2000 IU/mL, or chronic HBV infection evidence
- Stable antiviral therapy for at least 4 weeks prior to enrollment if receiving nucleos(t)ide analogs
- ECOG performance status of 0, 1, or 2
- Laboratory values meeting specified criteria for hemoglobin, neutrophil count, platelets, liver and kidney function
- 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 fertile patients unwilling to use contraception
- History of significant heart conditions including prolonged QTc interval, ventricular tachycardia, atrial fibrillation, heart block, recent myocardial infarction, congestive heart failure, or symptomatic coronary artery disease
- History of organ transplantation
- Recent treatment for myelotoxicity within 7 days before enrollment
- Active bleeding
- History or current thrombosis, embolism, cerebral hemorrhage, or infarction
- Active infection or persistent fever within 14 days before enrollment
- Incomplete recovery from major organ surgery less than 6 weeks prior
- Abnormal liver or kidney function exceeding specified limits
- Mental disorders or inability to provide informed consent
- Drug abuse or chronic alcoholism interfering with trial evaluation
- Lymphoma involving the central nervous system
- Investigator judgment deeming patient unsuitable for participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive maintenance treatment with Chidamide administered twice weekly in 4-week cycles, along with standardized antiviral prophylaxis, or antiviral prophylaxis alone in the control group.
Visits scheduled according to treatment cycles (approximately twice weekly dosing with periodic assessments)
Duration - Up to 24 months total including treatment
Participants are monitored for progression-free and overall survival after treatment completion.
Periodic follow-up visits during and after treatment
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
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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