NCT02800447Unknown不适用
Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol
Lee's Pharmaceutical Limited0 个研究点目标入组 92 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
- To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
- To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma
详细描述
This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen.
The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is of age 18~65, both male and female;
- •Newly pathologically diagnosed with classical Hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment;
- •Had stage IIB, III or IV disease, as assessed by the Ann Arbor classification;
- •ECOG≤2, life expectancy ≥3 month;
- •A negative serum pregnancy test required for sexually active women of childbearing potential;
- •The subject voluntarily gives written informed consent to participate in the study.
排除标准
- •Hematopoietic function:
- •Leukocyte <3,500/mm3（3.5×109/L）
- •Neutrophils <1,500/mm3（1.5×109/L）
- •Platelets <100,000/mm3（100×109/L）
- •Intolerance to any of the active ingredients and/or excipients in the study medications;
- •Severe central nervous system disorders and mental illness;
- •Severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). Echocardiography showed resting left ventricular ejection fraction (LVEF) < 50%);
- •History of severe lung disease;
- •AST or ALT>2.5×ULN，total bilirubin≥1.5×ULN，serum creatinine>1.5×ULN (for subject with liver metastases: AST or ALT>5xULN, total bilirubin ≥ 3xULN);
- •Uncontrolled, systemic, active infection；
- •Positive serology to HIV;
- •HBsAg positive subjects can still be enrolled in the study, but researchers should follow "The consensus on the Treatment of Lymphoma with Hepatitis B Infections" to observe closely and/or provide prophylactic anti-HBV therapy (as per investigator's decision);
- •Other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ;
- •The subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening;
- •The subject is pregnant or lactating; or subjects of childbearing potential (both women and man subjects) do not want to take effective contraceptive measures during study period or within 3 months after study completes;
- •Investigators believe subjects not suitable to participate in the study for other reasons.
研究组 & 干预措施
Treatment
Experimental
baseline BEACOPP regimen
干预措施: Natulan (Drug)
controlled group
Active Comparator
ABVD regimen
干预措施: ABVD (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: 45 months
Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma.
次要结局
- safety as measured by changes of vital signs, ECG and AE number(45 months)
研究者
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