Acute Lymphoblastic LeukemiaCoagCALLNCT06242353
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia
An observational study of Acute Lymphoblastic Leukemia and Thrombosis, run by Karolinska University Hospital.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Thrombosis, Bleeding
- What is being tested?
- Coagulopathy parameters
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Coagulopathy parameters
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Thrombosis, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulopathy parametersDiagnostic test
Also called Ultrasound
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
Secondary outcomes (2)
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)
Measured: 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
Measured: At the end of induction (protocol day 29 +/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Mats Heyman, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242353
- Sponsor's protocol ID
- K2021-5396
- Acronym
- CoagCALL
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment
- ClinicalTrials.gov ID
- NCT06242353
- Acronym / sponsor ID
- CoagCALL / K2021-5396
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coagulopathy parametersAlso: UltrasoundStandard 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 | Diagnostic test | – |
Primary outcome
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)
2 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Thrombosis, run by Karolinska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mats M Heyman, M.D., PhD (+46706287698, mats.heyman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.