Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ratio of dose delivered/dose planned
研究概览
简要总结
Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive 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
- 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
- •Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of >=20%, excluding APL
- •FLT3 mutation at initial diagnosis
- •Ineligibility of standard induction chemotherapy
- •Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)
排除标准
- •Previous treatment for AML (except HU and/or one cycle VEN+AZA according to SOC)
- •Previous treatment with Gilteritinib
- •Known active CNS involvement
- •QTcF >450 ms or long QT Syndrome at screening
- •Treatment with concomitant strong CYP3A inducers or St. John's wort
研究组 & 干预措施
Cohort 1
GILT d1-d28 VEN d1-d7 AZA d1-d7
干预措施: Gilteritinib (GILT) (Drug)
Cohort 1
GILT d1-d28 VEN d1-d7 AZA d1-d7
干预措施: Venetoclax (VEN) (Drug)
Cohort 1
GILT d1-d28 VEN d1-d7 AZA d1-d7
干预措施: Azacitidine (AZA) (Drug)
Cohort 2
GILT d8-d28 VEN d1-d7 AZA d1-d7
干预措施: Gilteritinib (GILT) (Drug)
Cohort 2
GILT d8-d28 VEN d1-d7 AZA d1-d7
干预措施: Venetoclax (VEN) (Drug)
Cohort 2
GILT d8-d28 VEN d1-d7 AZA d1-d7
干预措施: Azacitidine (AZA) (Drug)
Cohort 3
GILT d1-d28 VEN d1-d14 AZA d1-d7
干预措施: Gilteritinib (GILT) (Drug)
Cohort 3
GILT d1-d28 VEN d1-d14 AZA d1-d7
干预措施: Venetoclax (VEN) (Drug)
Cohort 3
GILT d1-d28 VEN d1-d14 AZA d1-d7
干预措施: Azacitidine (AZA) (Drug)
Cohort 4
GILT d8-d28 VEN d1-d14 AZA d1-d7
干预措施: Gilteritinib (GILT) (Drug)
Cohort 4
GILT d8-d28 VEN d1-d14 AZA d1-d7
干预措施: Venetoclax (VEN) (Drug)
Cohort 4
GILT d8-d28 VEN d1-d14 AZA d1-d7
干预措施: Azacitidine (AZA) (Drug)
结局指标
主要结局
Ratio of dose delivered/dose planned
时间窗: 12 months
次要结局
未报告次要终点