NCT01982175暂停2 期
A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia
Shanghai Zhangjiang Biotechnology Limited Company1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.
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
- •An established diagnosis of B-cell chronic lymphocytic leukemia(B-CLL)
- •Meet criteria of relapsed or refractory CLL
- •Presence of one or more measurable lesions
- •ECOG Score 0-1
- •Life expectancy > 3 months
- •Female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy.
排除标准
- •Less than 2 weeks from prior anti-cancer therapy.
- •Allergic to the antibody or any component of the investigational product.
- •Other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (Class III or IV), uncontrolled diabetes.
- •Use of investigational agents rather than Alemtuzumab.
- •Active systematic infection or major organ malfunction requiring treatment.
- •Serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or Serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or ALT and/or AST greater than or equal to 5 times upper limits of normal (liver metastases).
- •Blood urea nitrogen(BUN) greater than or equal to 1.5 times upper limits of normal or Serum creatinine greater than or equal to 1.5 times upper limits of normal.
- •White blood cell(WBC) count< 3.5×109/L or Absolute neutrophil count(ANC)<1.5×109/L or platelet count<75×109/L or Hemoglobin<80g/L.
- •Human immunodeficiency virus (HIV) positive.
- •Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization.
- •Pregnant or nursing women.
- •Known central nervous system(CNS) metastases with B-CLL.
- •Active secondary malignancy.
- •cytomegalovirus(CMV) positive or immunodeficiency disease or after stem cell transplantation.
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: up to 1 year
Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR). ORR=CR+PR
次要结局
- Progression-Free Survival(up to 1 year)
- Summary of patients with Adverse Events(AEs)(up to 1 year)
- Duration of Response(DOR)(up to 1 year)
- Overall Survival(up to 1 year)
- Disease Control Rate(DCR)(up to 1 year)
研究者
研究点 (1)
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