Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

Trial Title: Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

NCT ID: NCT06242353

Condition: Acute Lymphoblastic Leukemia
Thrombosis
Bleeding
Hemostatic Disorder

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Thrombosis
Hemostatic Disorders
Blood Coagulation Disorders

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Coagulopathy parameters
Description: Standard 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

Other name: Ultrasound

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.

Criteria for eligibility:

Study pop:
Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).

Sampling method: Non-Probability Sample
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)

Gender: All

Minimum age: 1 Year

Maximum age: 17 Years

Healthy volunteers: No

Start date: March 1, 2024

Completion date: November 2028

Lead sponsor:
Agency: Karolinska University Hospital
Agency class: Other

Collaborator:
Agency: Karolinska Institutet
Agency class: Other

Source: Karolinska University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06242353