Clinical trial · Interventional
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
NCT04661943CI-TRIAL-00106322completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tucidinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tucidinostat Group
- description
- 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.)
- interventionNames
- Drug: Tucidinostat
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6months
- description
- Progression-free survival(by IWC)
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 12months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.