NCT01098188已完成1 期
Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
Laboratoire français de Fractionnement et de Biotechnologies18 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2008年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 18
- 主要终点
- Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
研究概览
简要总结
This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Relapsed or refractory B-CLL after at least one prior course of therapy with fludarabine
- •Circulating lymphocytes expressing CD20
- •Peripheral blood lymphocyte count > 5,000/µL
- •ECOG performance status ≤ 2
- •Life expectancy ≥ 3 months
- •Negative blood pregnancy test before inclusion for women of childbearing potential
- •Medically acceptable method of birth control throughout the study for women of childbearing potential
- •Being considered as reliable and capable of adhering to the protocol and compliant with study procedures
- •Covered by healthcare insurance
排除标准
- •Transformation of CLL into a high grade lymphoma
- •Allogeneic stem cell transplantation < 6 months before enrolment
- •Prior treatment with anti-CD20 monoclonal antibodies < 6 months before enrolment
- •Prior treatment with alemtuzumab < 2 months before enrolment
- •Treatment with any IMP or participation in a clinical study within 30 days prior to enrolment
- •Known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of LFB-R603
- •Patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data
- •Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast
- •Patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives
- •Positive serology to HIV, HCV or presence of HBs Ag
- •Creatinine clearance, calculated according to Cockroft -Gault formula < 60 mL/min
- •ALT and /or AST level > 1.5 times the upper limit of normal
- •Pregnancy or breastfeeding
结局指标
主要结局
Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
时间窗: on going
次要结局
未报告次要终点
研究者
研究点 (18)
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