NCT00437086已完成早期 1 期
A Prospective Open-Label Pilot Trial of PS-341 (Bortezomib; VELCADE) for the Therapy of Symptomatic Advanced Myeloproliferative Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Proportion of patients who show treatment success, as defined by anemia, spleen, bone marrow, or constitutional symptoms' response (complete, partial, major, or minor response)
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
PURPOSE: This clinical trial is studying the side effects and how well bortezomib works in treating patients with advanced myeloproliferative disorders.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of bortezomib in patients with symptomatic advanced myeloproliferative disorders (i.e., myelofibrosis with myeloid metaplasia, chronic myelomonocytic leukemia, or FIP1LI-PDGFRA-negative mast cell disease).
- Determine the safety of this drug when administered on a modified schedule in these patients.
Secondary
- Determine the effect of this drug on bone marrow cellularity, tryptase-positive mast cells, reticulin fibrosis, osteosclerosis, and angiogenesis in responding patients
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PS-341
Experimental
Designed to assess the toxicity and pilot response of PS-341 in patients with advanced myeloproliferative diseases.
干预措施: PS-341 (Drug)
结局指标
主要结局
Proportion of patients who show treatment success, as defined by anemia, spleen, bone marrow, or constitutional symptoms' response (complete, partial, major, or minor response)
时间窗: 40 weeks
Number and severity of toxicities as assessed by NCI CTCAE v3.0
时间窗: 40 weeks
次要结局
- Effects of treatment, in terms of changes in bone marrow cellularity, tryptase-positive mast cells, reticulin fibrosis, osteosclerosis, and angiogenesis, in responding patients(40 weeks)
研究者
研究点 (3)
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