Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

Acute Lymphoblastic Leukemia Clinical Trial

— CoagCALL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242353
• Other study ID #: K2021-5396
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: November 2028

Study information

• Verified date: February 2024
• Source: Karolinska University Hospital
• Contact: Mats M Heyman, M.D., PhD
• Phone: +46706287698
• Email: mats.heyman[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2028
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Bleeding
• Blood Coagulation Disorders
• Hemostatic Disorder
• Hemostatic Disorders
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coagulation events (thrombosis and/or bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol	Incidence of coagulation events during the induction and consolidation phases (first 106 days of ALL-therapy)	From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
Secondary	Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy	Incidence of laboratory abnormalities during the induction and consolidation phases (first 106 days of ALL-therapy)	From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
Secondary	Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy	Thrombosis detected by ultrasound screening of catheterised neck veins	At the end of induction (protocol day 29 +/- 3 days)