Diffuse Large B-cell LymphomaPhase 2NCT04661943
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
A Phase 2 study testing Tucidinostat in people with Diffuse Large B-cell Lymphoma, run by Ou Bai, MD/PHD at 1 site in China.
Trial summary
A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Tucidinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histopathology confirmed DLBCL，with chronic hepatitis B before treatment
- After systemic treatment, complete response has been achieved and complete response lasted within 1year before enrollment
- The expected chemotherapy was completed and the laboratory indexes returned to normal
- The absolute value of neutrophil ≥ 1.5 × 10 9 / L, platelet count≥ 90 × 10 9 / L, hemoglobin level≥ 90 g / L
- Patients who cannot undergo hematopoietic stem cell transplantation for various reasons
- 18-75 years old, both male and female
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- ECOG PS 0-1
- Body weight: male 67 ± 20 kg (47-87 kg), female 55 ± 20 kg (35-75 kg)
- expected survival time ≥3 months
- Voluntary written informed consent prior to trail screening
Who cannot join
- Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures
- Patients with prolonged QTc interval (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and coronary heart disease with symptoms requiring drug treatment
- B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period
- Patients with previous or planned organ transplantation
- Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment
- HBV nucleic acid quantitation > 103 IU / ml
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- Patients with active bleeding
- Patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other this kind of diseases or medical history
- Patients with active infection or persistent fever within 14 days before enrollment
- less than 6 weeks after major organ surgery
- Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT / AST > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value)
- Mental disorders/Those who cannot obtain informed consent
- Patients with drug abuse and long-term alcohol abuse that affect evaluation
- The investigator determined not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
About this study
A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy
Read the detailed description
Objective to evaluate the efficacy and safety of maintenance therapy with Chidamide in patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma（DLBCL） with complete response after completion of prior chemotherapy, so as to provide the basis for the application of Chidamide in HBV positive DLBCL
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Tucidinostat
- Keywords
- DLBCL with HBV infection
- 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.
TucidinostatDrug
Also called Chidamide，CS055，HBI-8000
Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat Group | Experimental | Chidamide Specification: 5mg / tablet. Dosage: oral, 20 mg (4 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.) Receives: Drug: Tucidinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival（by IWC）
Measured: 6months
Secondary outcomes (1)
Overall survival
Overall survival
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jun 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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 LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661943
- Sponsor's protocol ID
- CDB0369
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2020
- Last updated
- 24 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04661943
- Acronym / sponsor ID
- CDB0369
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL with HBV infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ou Bai, MD/PHDUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Dec 2020 (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.
A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy
Detailed description
Objective to evaluate the efficacy and safety of maintenance therapy with Chidamide in patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma（DLBCL） with complete response after completion of prior chemotherapy, so as to provide the basis for the application of Chidamide in HBV positive DLBCL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat Group | Experimental | Drug: TucidinostatChidamide Specification: 5mg / tablet. Dosage: oral, 20 mg (4 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histopathology confirmed DLBCL，with chronic hepatitis B before treatment
- After systemic treatment, complete response has been achieved and complete response lasted within 1year before enrollment
- The expected chemotherapy was completed and the laboratory indexes returned to normal
- The absolute value of neutrophil ≥ 1.5 × 10 9 / L, platelet count≥ 90 × 10 9 / L, hemoglobin level≥ 90 g / L
- Patients who cannot undergo hematopoietic stem cell transplantation for various reasons
Key exclusion criteria (14 listed)
- Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures
- Patients with prolonged QTc interval (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and coronary heart disease with symptoms requiring drug treatment
- B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period
- Patients with previous or planned organ transplantation
- Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment
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 |
|---|---|---|
| TucidinostatAlso: Chidamide，CS055，HBI-8000Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.) | Drug | Tucidinostat Group |
Primary outcome
Progression-free survival
Time frame: 6months
Progression-free survival（by IWC）
1 secondary outcome
Overall survival
Time frame: 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucidinostat in people with Diffuse Large B-cell Lymphoma, 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6months). 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 24 Mar 2026.