Clinical trial NCT06242353: Coagulopathy in Childhood Acute Lymphoblastic Leukaemia
Official title: Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Thrombosis
Bleeding
Hemostatic Disorder
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2024-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).

Brief summary: 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: 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)

Primary outcomes:
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)
Secondary outcomes:
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)
measure: Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy
timeFrame: At the end of induction (protocol day 29 +/- 3 days)
Other outcomes:
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