临床试验/NCT00742144

NCT00742144已完成1 期

An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2008年9月19日最近更新: 2017年11月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 6
试验地点: 1
主要终点: tolerability

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.

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: 20 Years 至 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

ofatumumab

Experimental

Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

干预措施: ofatumumab (Drug)

结局指标

主要结局

tolerability

时间窗: eight weeks

次要结局

Adverse event,Clinical laboratory tests,Immunoglobulin,HAHA,Objective response rate,Duration of response,Progression free survival,CD5,19,20,CD23 positive cells,Complement (CH50),PK parameters,(nine months)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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