Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol
研究概览
简要总结
The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase.
The investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL.
Several pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute Lymphoblastic Leukaemia (ALL) in Sweden
- •Age 1-17.99 years at diagnosis
- •Planned/Initiated treatment for ALL according to the ALLTogether1 protocol
- •Signed informed consent from parents and patients (from 12 years - voluntary if <15 years)
排除标准
- •Other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for ALL (e g APS, moderate/severe v Willebrand disease, haemophilia)
- •Patient not treated according to the ALLTogether1 protocol (including patients with BCR::ABL1, mixed phenotype acute leukaemia - MPAL)
结局指标
主要结局
Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol
时间窗: From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
Incidence of coagulation events during the induction and consolidation phases (first 106 days of ALL-therapy)
次要结局
- Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy(At the end of induction (protocol day 29 +/- 3 days))
- Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy(From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy))
研究者
Mats Heyman
Associate Professor, Consultant
Karolinska University Hospital