NCT05697510招募中1 期
Monocentric Phase 1 Study With Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- number of DLT
研究概览
简要总结
This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.
详细描述
Administration of siltuximab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 years
- •AML with a poor prognosis defined according to the criteria below:
- •LAM First line: Age <60 years and unfavorable risk according to the 2017 ELN Age> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age
- •ECOG <= 2
- •Patient eligible for intensive chemotherapy
- •Informed consent
- •Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
- •Creatinine clearance> 60ml / min
- •LVEF> = 50%
排除标准
- •Patients with FLT3 ITD or TKD mutation eligible for FLT3 inhibitor therapy
- •Uncontrolled infection
- •Hep B, C, HIV +
- •History of diverticulosis / diverticulitis
- •Patients at high risk of gastrointestinal perforation
- •No social security or any other scheme
- •Pregnant women or patient unable to take contraception (pill, abstinence, IUD not allowed) in case of fertility. contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last SILTUXIMAB injection is not eligible for inclusion.
- •Lactating women
- •Adults under guardianship, curatorship or legal protection
- •Hypersensitivity to one of the active substances or to one of the excipients
研究组 & 干预措施
SILTUXIMAB
Experimental
干预措施: Siltuximab (Drug)
结局指标
主要结局
number of DLT
时间窗: 45 days
次要结局
- Evaluation of the response to induction therapy with idarubicin + cytarabine + siltuximab(Day 30 and Day 45)
- Evaluation of response at D15 after induction(Day 15)
- Assessment of myelotoxicity(Day 45)
- Overall survival(Month 6)
- Leukaemia-free survival(Month 6)
- Event-free survival(Month 6)
- Incidence of relapse if remission(Month 6)
- Infections(Month 6)
- Cytokine levels: FLT3L and IL-6(Day 1, Day 8, Day 15, Day 22)
研究者
研究点 (1)
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