NCT06915766Available不适用
Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 31
研究概览
简要总结
The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.
研究设计
- 研究类型
- Expanded Access
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
- •Able to provide written informed consent and commit to EAP assessments.
- •≥18 years of age.
- •Able to swallow tablets.
- •Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
- •Not receiving adequate disease control on current therapy(ies).
- •Have clinically acceptable laboratory screening results.
排除标准
- •Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
- •Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
- •Pregnant or currently breastfeeding.
- •Prior or ongoing clinically significant illness or medical or physical condition
- •Other protocol-defined criteria apply.
研究者
研究点 (31)
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