Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL with HBV infection
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
Interventions
DRUGTucidinostat
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.)
Sponsors
Ou Bai, MD/PHD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 6months | Progression-free survival（by IWC） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12months | Overall survival |
Countries
China
Outcome results
None listed