NCT07623200招募中3 期
A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 426
- 试验地点
- 180
研究概览
简要总结
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Confirmed diagnosis of high-risk ET.
- •Presence of mutCALR.
- •Prior treatment with at least 1 cytoreductive therapy.
排除标准
- •Presence of any hematologic malignancy other than ET.
- •Major bleeding or thrombosis within the last 3 months prior to study enrollment.
- •Any prior allogenic or autologous stem-cell transplantation.
- •Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
- •Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.
- •Other protocol-defined Inclusion/Exclusion Criteria apply.
研究组 & 干预措施
INCA033989
Experimental
Administered intravenous (IV) in accordance with the protocol-defined requirements.
干预措施: INCA033989 (Drug)
Best Available Therapy (BAT)
Experimental
Best Available Therapy (BAT) will be selected by the investigator.
干预措施: Best Available Treatment (Drug)
研究者
研究点 (180)
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