NL-OMON37318已完成2 期
A single arm, phase II, open-label study to determine the efficacy of 100mg twice daily oral dosing of Midostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease - AgressiveSystemicMastocytosis (ASM) or MastCell Leukemia (MCL), midostaurin
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients with diagnosis of one major plus at least one minor criterion, or the presence of at least 3 minor criteria according to WHO criteria for Systemic Mastocytosis (Valent et al. 2001);Patient must present with at least one measurable C-Finding.;For patients with MCL: bone marrow aspirate smears must show 20% or more immature mast cells.
排除标准
- •Patients who have demonstrated relapse to more than two prior regimen of SM treatment-regardless of treatment regimen for supportive care (e.g. symptom limiting therapies);Patients who have aggressive systemic mastocytosis with eosinophilia and known positivity for the FIP1L1-PDGFR fusion unless they have demonstrated relapse or disease progression on prior imatinib therapy;Patients on imatinib therapy and known to be KIT D816V negative unless they have demonstrated relapse, resistance or intolerance to imatinib.;Patients with any pulmonary infiltrate including those suspected to be of infectious origin.
研究者
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