Study of the Medullary Microenvironment in Acute Childhood Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorUniversity Hospital, Tours
About this trial
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Child with acute lymphoblastic or myeloblastic leukemia at diagnosis
Not having received prior hematological treatment
Aged 1 to 15 years old
Whose 2 parents, or the holder of parental authority, have signed a consent enlightened.
Disqualifiers
Patient under 1 year old and over 15 years old.
Contraindication to myelogram.
Absence of signature of the informed consent by the 2 parents or the holder of parental authority.
Patients with relapsed acute lymphoblastic or myeloblastic leukemia.
Trial design
Design model
Parallel
Treatments tested in this trial
Biological sampling in patients
Procedure/Surgeryblood and bone marrow samples from patients with Acute Leulemia.
Biological sampling in control patients
Procedure/Surgeryblood and bone marrow samples from children undergoing orthopedic surgery exposing the bone marrow.(osteotomy of the pelvis).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Patients with acute leukemiasActive comparator 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Oxygen Consumption Rate
Difference in oxidative phosphorylation measured by OCR (Oxygen Consumption Rate) in pmol/min/nd DNA between the mesenchymal stromal stem cells (MSCs) of children with Acute Leukemia and those of children without blood diseases.
Time frame
At inclusionSecondary outcomes
1
Difference in Extra Cellular Acidification Rate
Difference in glycolysis, measured by the ECAR (Extra Cellular Acification Rate) in mpH/min/ng DNA between the MSCs of children with AL and those of children without hematological disease.
Time frame
At inclusion2
Difference in Reactive Oxygen Species
Difference in oxidative metabolism thanks to the measurement of reactive oxygen species (ROS), measured in MIF/isotype, between MSCs of children with AL and those of children without hematological disease
Time frame
At inclusion3
Difference in doubling time in culture
The difference in doubling time in culture (measured in days) between the MSCs of children with LA and those of children free of hemopathy. At each passage, the number of living and dead MSCs will be counted.
Time frame
At inclusion4
Difference in Immunophenotypic profile
The difference in immunophenotypic profile (cytometry, immunofluorescence) between MSCs of children with AL and those of children without hematological disease. Use of a panel of monoclonal antibodies directed against various membrane antigens (CD45, CD34, CD14, CD90, CD73, CD105).
Time frame
At inclusionSponsors and contacts
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Source ClinicalTrials.gov