Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 41
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
- •Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
- •Age ≥ 18 years and ≤ 60 years
- •Adequate hepatic function within 48 hours prior to induction chemotherapy
- •Adequate renal functions within 48 hours prior to induction chemotherapy
- •ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
- •Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
排除标准
- •Acute promyelocytic leukemia (APL)
- •Known clinically active central nervous system (CNS) leukemia
- •Severe liver disease
- •Active infections
- •Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Known infection with human immunodeficiency virus (HIV)
- •Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
研究组 & 干预措施
Midostaurin
Midostaurin following salvage chemotherapy
干预措施: Duanorubicin (Drug)
Crenolanib
Crenolanib following salvage chemotherapy
干预措施: Duanorubicin (Drug)
Crenolanib
Crenolanib following salvage chemotherapy
干预措施: Crenolanib (Drug)
Crenolanib
Crenolanib following salvage chemotherapy
干预措施: Cytarabine (Drug)
Midostaurin
Midostaurin following salvage chemotherapy
干预措施: Midostaurin (Drug)
Midostaurin
Midostaurin following salvage chemotherapy
干预措施: Cytarabine (Drug)
结局指标
主要结局
Event-free survival (EFS)
时间窗: 5 years
次要结局
- Relapse free survival(5 years)
- Composite complete remission rate(5 years)
- Overall Survival(7 years)
- Duration of response(5 years)