Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia; Thrombosis; Hemostatic Disorder; Bleeding

• Registration Number: NCT06242353
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Study Start: 2024-03-01
• Primary Completion: 2026-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol	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)

Secondary Outcome Measures

Name	Time	Method
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)	Thrombosis detected by ultrasound screening of catheterised neck veins
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)	Incidence of laboratory abnormalities during the induction and consolidation phases (first 106 days of ALL-therapy)