NCT00283114已完成1 期
A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 82
- 试验地点
- 9
- 主要终点
- Antitumor activity.
研究概览
简要总结
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
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
- •Patients must have a diagnosis of MDS or AML.
- •Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
排除标准
- •Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
- •Patients with a prior allogeneic transplant.
- •Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
- •Patients receiving chemotherapy within the last four weeks.
研究组 & 干预措施
1
Experimental
干预措施: lintuzumab (Drug)
结局指标
主要结局
Antitumor activity.
时间窗: 13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
时间窗: 13 months
The incidence of adverse events and lab abnormalities.
时间窗: 13 months
次要结局
未报告次要终点
研究者
研究点 (9)
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