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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04661943
• Other study ID #: CDB0369
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2020
• Source: First Hospital of Jilin University
• Contact: ou BAI, doctor
• Phone: 13039046656
• Email: oubai16[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Tucidinostat
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.)

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
oubai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival(by IWC)	6months
Secondary	Overall survival	Overall survival	12months