NCT07212023尚未招募2 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With a KMT2A or NUP98 Gene Rearrangement (REVEAL-ND KMT2A)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 235
- 主要终点
- Event-free Survival (EFS)
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 acute myeloid leukemia (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 weigh ≥ 40 kilograms (kg).
- •Participants must have newly diagnosed and previously untreated AML and be candidates for intensive induction chemotherapy.
- •Presence of a KMT2A rearrangement or NUP98 rearrangement.
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2, or 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
- •Not a candidate for anthracycline based therapy for Induction.
- •Not a candidate for continuous infusion cytarabine during Induction or intermediate dose cytarabine for Consolidation.
- •Diagnosis of active acute promyelocytic leukemia.
- •Active central nervous system (CNS) disease (cytologic, such as any blasts on cytospin, or radiographic).
- •QTc using Fridericia's correction (QTcF) > 450 milliseconds (msec) at Screening or history of long QT Syndrome.
- •Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion (for example, gastric bypass, gastroparesis, etc).
- •Any uncontrolled active infection.
- •Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
- •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: Intensive Chemotherapy Regimen (Drug)
Placebo + Intensive Chemotherapy
Placebo Comparator
Participants will receive placebo plus an intensive chemotherapy regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Event-free Survival (EFS)
时间窗: Up to approximately 2 years
次要结局
- Overall Response Rate (ORR)(Up to approximately 2 years)
- Complete Remission (CR) Rate(Up to approximately 2 years)
- Composite Complete Remission (CRc) Rate(Up to approximately 2 years)
- Duration of CR(Up to approximately 2 years)
- Duration of CRc(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Measurable Residual Disease Complete Remission Rate(Up to approximately 2 years)
- Number of Participants with a Treatment-emergent Adverse Event (TEAE)(Up to approximately 2 years)
- Change from Baseline in Patient-reported Fatigue Questionnaire Scores(Up to 2 years)
研究者
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