Coagulopathy in Childhood Acute Lymphoblastic Leukaemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorKarolinska University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Coagulopathy parameters
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Karolinska University Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov