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Not yet recruiting NCT06242353

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

— Observational Acute Lymphoblastic Leukemia Thrombosis Bleeding Hemostatic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coagulopathy parameters.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Thrombosis, Bleeding, Hemostatic Disorder. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • 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)]
  • 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)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06242353 · K2021-5396

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗