Clinical trial · Observational
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Bleeding | — | UNRESOLVED | — |
| Hemostatic Disorder | — | UNRESOLVED | — |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coagulopathy parameters | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol
- timeFrame
- From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
- description
- Incidence of coagulation events during the induction and consolidation phases (first 106 days of ALL-therapy)
Secondary outcomes (2)
- measure
- Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy
- timeFrame
- From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
- description
- Incidence of laboratory abnormalities during the induction and consolidation phases (first 106 days of ALL-therapy)
- measure
- Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available