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NCT Number: NCT06242353

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Bleeding Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorder Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Thrombosis Vascular Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coagulopathy parameters

Diagnostic Test

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 names: Ultrasound

Primary outcomes

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

Time frame: 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 outcomes

Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy

Time frame: 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)
Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy

Time frame: At the end of induction (protocol day 29 +/- 3 days)

Thrombosis detected by ultrasound screening of catheterised neck veins

Study contacts

Contact information is provided by the study sponsor or research team.

Lovisa H Malmqvist, M.D.

CONTACT

[email protected]

+46739453399

Mats M Heyman, M.D., PhD

CONTACT

[email protected]

+46706287698

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

Karolinska Institutet

Registry information

Official study title

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment

Acronym: CoagCALL

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2028
First posted: Feb 5, 2024
Registry last updated: Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed