NCT03045471Unknown不适用
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- progression-free survival
研究概览
简要总结
- Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged 18-60 years old;
- •Confirmed as AIDS patients and treated with HAART;
- •Confirmed as CD20+ diffuse large B lymphoma;
- •Serum test; negative for HBV, HCV and syphilis;
- •Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3); Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3);
- •Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl;
- •Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;
- •Negative pregnancy test for female;
- •Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment;
- •To be able to understand and sign the Informed Consent Document with legal force.
排除标准
- •With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
- •Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
- •Women with pregnant or breastfeeding;
- •Any form of primary immunodeficiency;
- •Concurrent Systemic steroid therapy;
- •History of severe immediate hypersensitivity reaction to any of the agents used in this study;
- •History of allogeneic stem cell transplantation.
研究组 & 干预措施
R-EPOCH
干预措施: R-EPOCH (Drug)
R-CHOP
干预措施: R-CHOP (Drug)
结局指标
主要结局
progression-free survival
时间窗: 3 years
次要结局
- complete response rate(3 years)
- partial response partial response rate(3 years)
- overall response(3 years)
研究者
Hongzhou Lu
Professor
Shanghai Public Health Clinical Center
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