NCT07211958招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 116
- 主要终点
- Event Free Survival
研究概览
简要总结
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
- •Presence of an NPM1 mutation.
- •Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥
- •Have a life expectancy of ≥3 months as judged by the Investigator.
- •Negative serum pregnancy test.
- •Adequate liver, kidney, and cardiac function.
排除标准
- •Diagnosis of active acute promyelocytic leukemia.
- •Active central nervous system disease.
- •Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- •Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
- •Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
- •Inability to swallow oral medication.
- •Pregnant or nursing females.
- •Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Revumenib + Intensive Chemotherapy
Experimental
Participants will receive revumenib plus an intensive chemotherapy regimen.
干预措施: Revumenib (Drug)
Revumenib + Intensive Chemotherapy
Experimental
Participants will receive revumenib plus an intensive chemotherapy regimen.
干预措施: Intensive Chemotherapy Regimen (Drug)
Placebo + Intensive Chemotherapy
Placebo Comparator
Participants will receive placebo plus an intensive chemotherapy regimen.
干预措施: Placebo (Drug)
Placebo + Intensive Chemotherapy
Placebo Comparator
Participants will receive placebo plus an intensive chemotherapy regimen.
干预措施: Intensive Chemotherapy Regimen (Drug)
结局指标
主要结局
Event Free Survival
时间窗: Up to 2 years
Measurable Residual Disease Complete Remission Rate
时间窗: Up to 2 years
次要结局
- Rate of Composite Complete Remission(Up to 2 years)
- Overall Survival(Up to 5 years)
- Rate of Complete Remission(Up to 2 years)
- Overall Response Rate(Up to 2 years)
- Duration of Complete Remission(Up to 2 years)
- Duration of Composite Complete Remission(Up to 2 years)
- Duration of Response(Up to 2 years)
- Number of Participants with a Treatment-emergent Adverse Event(Up to 2 years)
- Change from Baseline in Patient-reported Fatigue Questionnaire Scores(Up to 2 years)
研究者
研究点 (116)
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