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 Clinical Trial

— THROMBLEUKEMIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862652
• Other study ID #: PA13047
• Status: Completed
• Phase: N/A
• First received: August 8, 2016
• Last updated: March 31, 2017
• Start date: May 2014
• Est. completion date: March 21, 2017

Study information

• Verified date: March 2017
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 21, 2017
• Est. primary completion date: March 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• children with acute lymphoblastic leukemia

• children and their parents consenting to participate to the study

• children enrolled in the national healthcare insurance program

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Blood sample
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of microparticules	Presence of microparticles investigated using flow cytometry	Day 0
Secondary	Presence of microparticules	Presence of microparticles investigated using flow cytometry	Day 8
Secondary	Presence of microparticules	Presence of microparticles investigated using flow cytometry	Day 15
Secondary	Presence of microparticules	Presence of microparticles investigated using flow cytometry	Day 25
Secondary	Presence of microparticules	Presence of microparticles investigated using flow cytometry	Day 36
Secondary	expression of the tissue factor	expression of the tissue factor investigated using flow cytometry	Day 0
Secondary	expression of the tissue factor	expression of the tissue factor investigated using flow cytometry	Day 3
Secondary	expression of the tissue factor	expression of the tissue factor investigated using flow cytometry	Day 15
Secondary	expression of the tissue factor	expression of the tissue factor investigated using flow cytometry	Day 25
Secondary	expression of the tissue factor	expression of the tissue factor investigated using flow cytometry	Day 36
Secondary	Thromboembolic complication	complication thromboembolic diagnosed by the clinical examination and by the imaging	Day 36