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
This trial does not accept healthy volunteersQualifiers
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 population
Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Coagulopathy parameters
Diagnostic testStandard coagulation tests: APT (Activated Partial Thromboplastin Time), PT/INR (Prothrombin Time Test), Protein-C, Protein-S, Fibrinogen, Antithrombin, D-dimers. Global haemostasis assays: CAT (Calibrated Automated Thrombogram), OHP (Overall Haemostatic Potential), Fibrin clot turbidity assay, microparticle detection by flow cytometry, scanning electron microscopy. Protein expression profile (mass spectroscopy) Ultrasound of catheterised neck veins to detect clots
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol
Incidence of coagulation events during the induction and consolidation phases (first 106 days of ALL-therapy)
Time frame
From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)Secondary outcomes
1
Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy
Incidence of laboratory abnormalities during the induction and consolidation phases (first 106 days of ALL-therapy)
Time frame
From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)2
Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy
Thrombosis detected by ultrasound screening of catheterised neck veins
Time frame
At the end of induction (protocol day 29 +/- 3 days)Locations
Sponsors and contacts
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Karolinska University Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: