NCT04661943已完成2 期
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Ou Bai, MD/PHD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Progression-free survival
时间窗: 6months
Progression-free survival（by IWC）
次要结局
- Overall survival(12months)
研究者
Ou Bai, MD/PHD
Director
The First Hospital of Jilin University
研究点 (1)
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