Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
- Registration Number
- NCT04661943
- Lead Sponsor
- oubai
- Brief 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
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A Tucidinostat Chidamide 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.)
- Primary Outcome Measures
Name Time Method Progression-free survival 6months Progression-free survival（by IWC）
- Secondary Outcome Measures
Name Time Method Overall survival 12months Overall survival
Trial Locations
- Locations (1)
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China