Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

NCT ID: NCT06242353

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-11-30

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.

Conditions

Acute Lymphoblastic Leukemia; Thrombosis; Bleeding; Hemostatic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Coagulopathy parameters

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Ultrasound

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mats Heyman

Associate Professor, Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mats M Heyman, M.D., PhD

Role: CONTACT

mats.heyman@ki.se

+46706287698

Lovisa H Malmqvist, M.D.

Role: CONTACT

lovisa.2.malmqvist@ki.se

+46739453399

Other Identifiers

K2021-5396

Identifier Type: -

Identifier Source: org_study_id