Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
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
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Bethune Hospital of Jilin University | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
oubai |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Progression-free survival(by IWC) | 6months | |
Secondary | Overall survival | Overall survival | 12months |
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