Acute Lymphoblastic LeukemiaTHROMBLEUKEMIANCT02862652
Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children.
A study testing Blood sample in people with Acute Lymphoblastic Leukemia, run by CHU de Reims at 1 site in France.
Trial summary
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to 21 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with acute lymphoblastic leukemia
- children and their parents consenting to participate to the study
- children enrolled in the national healthcare insurance program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.
The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.
Read more
The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.
In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.
Read the detailed description
The aims of this study are
- quantify the microparticles in children receiving induction therapy for Acute lymphoblastic leukemia at diagnosis and during treatment
- study the origin of these particles and the expression and activity of the tissue factor on their surface, at diagnosis and during treatment
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Blood sample
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
| Study group | Role | What they receive |
|---|---|---|
| children with acute lymphoblastic leukemia | Experimental | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Measured: Day 0
Secondary outcomes (10)
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Measured: Day 8
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Measured: Day 15
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Measured: Day 25
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Measured: Day 36
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Measured: Day 0
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Measured: Day 3
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Measured: Day 15
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Measured: Day 25
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Measured: Day 36
Thromboembolic complication
complication thromboembolic diagnosed by the clinical examination and by the imaging
Measured: Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2014
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862652
- Sponsor's protocol ID
- PA13047
- Acronym
- THROMBLEUKEMIA
- Status last verified
- Mar 2017
- First submitted
- 8 Aug 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
Pluchart C, Barbe C, Poitevin G, Audonnet S, Nguyen P. A pilot study of procoagulant platelet extracellular vesicles and P-selectin increase during induction treatment in acute lymphoblastic leukaemia paediatric patients: two new biomarkers of thrombogenic risk? J Thromb Thrombolysis. 2021 Apr;51(3):711-719. doi: 10.1007/s11239-020-02346-7. Epub 2020 Nov 28.
PubMed 33247807
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children
- ClinicalTrials.gov ID
- NCT02862652
- Acronym / sponsor ID
- THROMBLEUKEMIA / PA13047
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.
The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.
The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.
In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.
Detailed description
The aims of this study are
- quantify the microparticles in children receiving induction therapy for Acute lymphoblastic leukemia at diagnosis and during treatment
- study the origin of these particles and the expression and activity of the tissue factor on their surface, at diagnosis and during treatment
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with acute lymphoblastic leukemia | Experimental | Other: Blood sample |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with acute lymphoblastic leukemia
- children and their parents consenting to participate to the study
- children enrolled in the national healthcare insurance program
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood sampleBlood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface | Other | children with acute lymphoblastic leukemia |
Primary outcome
Presence of microparticules
Time frame: Day 0
Presence of microparticles investigated using flow cytometry
10 secondary outcomes
Presence of microparticules
Time frame: Day 8
Presence of microparticules
Time frame: Day 15
Presence of microparticules
Time frame: Day 25
Presence of microparticules
Time frame: Day 36
expression of the tissue factor
Time frame: Day 0
expression of the tissue factor
Time frame: Day 3
expression of the tissue factor
Time frame: Day 15
expression of the tissue factor
Time frame: Day 25
expression of the tissue factor
Time frame: Day 36
Thromboembolic complication
Time frame: Day 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33247807Pluchart C, Barbe C, Poitevin G, Audonnet S, Nguyen P. A pilot study of procoagulant platelet extracellular vesicles and P-selectin increase during induction treatment in acute lymphoblastic leukaemia paediatric patients: two new biomarkers of thrombogenic risk? J Thromb Thrombolysis. 2021 Apr;51(3):711-719. doi: 10.1007/s11239-020-02346-7. Epub 2020 Nov 28.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Acute Lymphoblastic Leukemia, run by CHU de Reims at 1 site in France.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of microparticules (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862652, which also lists 1 linked publication.
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 21 Jan 2026.