Clinical trial NCT04661943: Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Official title: Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 6months
Secondary outcomes:
measure: Overall survival
timeFrame: 12months
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: