Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP

Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial

Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (NCT07493109) is a Phase 3 interventional studying Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Ou Bai, MD/PHD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Diffuse Large B-Cell Lymphoma (DLBCL), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Diffuse Large B-Cell Lymphoma (DLBCL) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Both sexes, age range ≥18 years and ≤80 years. 2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group). 3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (\>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis). 6. expected to live at least 6 months, as judged by the investigator. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Both sexes, age range ≥18 years and ≤80 years. 2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group). 3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (\>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis). 6. Life expectancy of at least 6 months, as judged by the investigator. 7. Understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures. 2. Patients with a history of clinically significant QTc interval prolongation (males \> 450 ms, females \> 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication. 3. Patients who have undergone organ transplantation. 4. Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment. 5. Patients with active bleeding. 6. Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions. 7. Patients with active infection, or persistent fever within 14 days before enrollment. 8. Patients who have not completed at least 6 weeks of recovery after major organ surgery. 9. Patients with abnormal liver function (total bilirubin \> 1.5 × upper limit of normal \[ULN\], ALT/AST \> 2.5 × ULN, or \> 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine \> 1.5 × ULN). 10. Patients with mental disorders or those from whom informed consent cannot be obtained. 11. Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results. 12. Patients with lymphoma involving the central nervous system (CNS). 13. Patients deemed by the investigator to be unsuitable for participation in this study.

Treatments Being Tested

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)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07493109), the sponsor (Ou Bai, MD/PHD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07493109 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07493109?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07493109?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07493109. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07493109. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.