Diffuse Large B-Cell Lymphoma (DLBCL)Phase 3NCT07493109
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP
A Phase 3 study testing Chidamide and Entecavir Tablets in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Ou Bai, MD/PHD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Chidamide and Entecavir Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes, age range ≥18 years and ≤80 years.
- 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).
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- 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).
- Life expectancy of at least 6 months, as judged by the investigator.
- Understand and voluntarily sign a written informed consent form.
Who cannot join
- Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
- 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.
- Patients who have undergone organ transplantation.
- Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
- Patients with active bleeding.
- Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
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- Patients with active infection, or persistent fever within 14 days before enrollment.
- Patients who have not completed at least 6 weeks of recovery after major organ surgery.
- 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).
- Patients with mental disorders or those from whom informed consent cannot be obtained.
- Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
- Patients with lymphoma involving the central nervous system (CNS).
- Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
Ou Bai, PHD, 15804302602, oubai16@163.com
About this study
Official title: 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
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.
Read the detailed description
Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Chidamide, Entecavir Tablets
- Keywords
- HBV-infected DLBCL
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called Tucidinostat, HBI-8000, CS055
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.
Entecavir TabletsDrug
Also called ETV
Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Chidamide group | Experimental | 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. Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) Receives: Drug: Chidamide |
| Control group | Active comparator | Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) Receives: Drug: Entecavir Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: 24 months
Secondary outcomes (2)
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) referred to Lugano 2014.
Measured: 24 months
Overall survival（OS）
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ou Bai, MD/PHD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
- Investigators
- Ou Bai, PHD, Principal investigator, The First Bethune Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493109
- Sponsor's protocol ID
- HBV-DLBCL
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07493109
- Acronym / sponsor ID
- HBV-DLBCL
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- HBV-infected DLBCL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ou Bai, MD/PHDUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide group | Experimental | Drug: ChidamideChidamide 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. Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) |
| Control group | Active comparator | Drug: Entecavir TabletsStandardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both sexes, age range ≥18 years and ≤80 years.
- 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).
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- 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).
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
- 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.
- Patients who have undergone organ transplantation.
- Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
- Patients with active bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideAlso: Tucidinostat, HBI-8000, CS055Chidamide 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 | Chidamide group |
| Entecavir TabletsAlso: ETVStandardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) | Drug | Control group |
Primary outcome
Progression-free survival (PFS)
Time frame: 24 months
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: 24 months
Overall survival（OS）
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ou Bai, PHD principal investigator
The First Bethune Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chidamide and Entecavir Tablets in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Ou Bai, MD/PHD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ou Bai, PHD (15804302602, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.