Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales
研究概览
简要总结
This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients, >/= 18 years of age
- •Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US
- •Life expectancy > 12 weeks
- •Zubrod performance status </= 3
排除标准
- •Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial
- •Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1
- •Active infection requiring iv antibiotics for > 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed
- •Active viral infection within 28 days prior to Day 1
- •Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline
研究组 & 干预措施
Single Arm
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales
时间窗: until disease progression or significant toxicity occurs
Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays
时间窗: up to 90 days after discontinuation of treatment
Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab
时间窗: until disease progression or significant toxicity occurs
次要结局
未报告次要终点