Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma

oubai

Status and phase: Unknown; Phase 2

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: Tucidinostat

Study type: Interventional

Funder types: Other

Identifiers

NCT04661943

CDB0369

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm A

Experimental group

Description:

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.)

Treatment:

Drug: Tucidinostat