NCT00651443终止1 期
A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
研究概览
简要总结
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (signed and dated).
- •Age equal or greater than 18 at the time of consent.
- •Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
- •At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
- •Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
- •Acceptable hematologic, hepatic, and renal function parameters.
- •WHO Performance Status equal or less than
- •Subjects of reproductive potential must agree to follow accepted birth control methods.
排除标准
- •Presence of lymphoma in CNS.
- •Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
- •Concurrent treatment with systemic steroids within 14 days of Day
- •Evidence of transformed lymphoma.
- •Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
- •History of HIV infection or AIDS.
- •Serious nonmalignant disease.
- •Pregnant.
- •Inability to comply with study and follow-up procedures.
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
研究组 & 干预措施
1
Experimental
干预措施: Galiximab (Drug)
结局指标
主要结局
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
时间窗: 24 months
次要结局
- 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.(48 months)
研究者
研究点 (1)
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