Status:
UNKNOWN
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Lead Sponsor:
oubai
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04661943
Start Date
November 30 2020
End Date
November 30 2022
Last Update
December 10 2020
Active Locations (1)
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1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021