NCT00502112已完成1 期
A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)
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
- 13
- 试验地点
- 8
- 主要终点
- The incidence of adverse events and lab abnormalities
研究概览
简要总结
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.
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
- •Disease confirmation of MDS.
- •Between 5% and 30% blasts in the bone marrow.
- •Received treatment for cytopenias within 2-months
排除标准
- •Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
- •Received chemotherapy/radiotherapy within 4 weeks of study registration.
- •Received prior bone marrow transplant.
- •5q- chromosomal deletion in malignant cells.
研究组 & 干预措施
1
Experimental
lintuzumab and lenalidomide
干预措施: lintuzumab (Drug)
1
Experimental
lintuzumab and lenalidomide
干预措施: lenalidomide (Drug)
结局指标
主要结局
The incidence of adverse events and lab abnormalities
时间窗: 1 month after last dose
次要结局
- Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)(1 month after last dose)
- Antitumor activity(Every other 21-day cycle)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
1 期
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic SyndromeMyeloproliferative DisordersAcute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic LeukemiaNCT00283114Seagen Inc.82
已完成
1 期
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)Advanced or Metastatic HCCNCT00746317Chugai Pharmaceutical27
已完成
1 期
Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)Hepatocellular CarcinomaNCT00976170Chugai Pharmaceutical42
已完成
1 期
A Safety Study of SGN-CD33A in AML PatientsAcute Myelogenous LeukemiaAcute Myeloid LeukemiaAcute Promyelocytic LeukemiaNCT01902329Seagen Inc.195
已完成
1 期
A Safety Study of SGN-40 in Patients With Non-Hodgkin's LymphomaNon-Hodgkin LymphomaNCT00103779Seagen Inc.50