Coagulopathy in Childhood Acute Lymphoblastic Leukaemia (CoagCALL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombosis; Bleeding; Acute Lymphoblastic Leukemia; Hemostatic Disorder
• Intervention / Treatment: Diagnostic test: Coagulopathy parameters

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mats M Heyman, M.D., PhD; Phone Number: +46706287698; Email: mats.heyman@ki.se
• Study Contact Backup: Name: Lovisa H Malmqvist, M.D.; Phone Number: +46739453399; Email: lovisa.2.malmqvist@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Hemostatic Disorders; Blood Coagulation Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Thrombosis
• Other Study ID Numbers: K2021-5396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When study has been completed and published, IPD may be shared with other researchers on collaborative basis, provided that data protection for study subjects can be ensured and that no violation of data-protection legislation will occur.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No