A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of lenzilumab (as measured by the number of participants with adverse events) at various doses in order to determine a recommended Phase 2 dose
研究概览
简要总结
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
详细描述
The purpose of the study is to examine the safety and determine the recommended Phase 2 dose of lenzilumab when administered to subjects with previously treated CMML who meet the entry criteria. Study will begin enrollment in July 2016.
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
- •Confirmed diagnosis of CMML
- •CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 2
- •Able to provide bone marrow biopsy samples
- •Acceptable laboratory results
排除标准
- •Leukemia other than CMML
- •Recent chemotherapy or radiation therapy (within 14 days before first dose of lenzilumab)
- •Concurrent use of human granulocyte-macrophage colony-stimulating factor
- •Pregnant or breastfeeding
- •Know HIV virus infection
- •History of another malignancy within the past 2 years (some skin cancer and prostate cancers permitted)
- •Significant intercurrent illness
- •History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia
研究组 & 干预措施
Single Agent lenzilumab
Dose levels: lenzilumab IV infusion once monthly for a 28 day dosing cycle (with extra dose on Day 15 during cycle). Three (3) to Six (6) subjects will be enrolled into planned escalating cohorts of 200 mg, 400 mg or 600 mg lenzilumab.
干预措施: lenzilumab (Drug)
结局指标
主要结局
Safety of lenzilumab (as measured by the number of participants with adverse events) at various doses in order to determine a recommended Phase 2 dose
时间窗: Up to an average of 12 months
次要结局
- Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)(Up to an average of 12 months)