Study of the Medullary Microenvironment in Acute Childhood Leukemia

NCT05792007 | Recruiting

• 2 other identifiers: DR220254-MILA2022-A02570-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Lymphoid Leukemia; Acute Myeloid Leukemia in Children

Outcome Measures

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.

  At inclusion

Secondary Outcomes (7)

• Difference in Extra Cellular Acidification Rate

  At inclusion

• Difference in Reactive Oxygen Species

  At inclusion

• Difference in doubling time in culture

  At inclusion

• Difference in Immunophenotypic profile

  At inclusion

• Difference in mutational profiles between MSCs and leukemia cells

  At inclusion

Study Arms (2)

Patients with acute leukemias

ACTIVE COMPARATOR

Children with acute lymphoid leukemia B, acute lymphoid leukemia -T or acute myeloid leukemia

Procedure: Biological sampling in patients

Control group

OTHER

Children without blood diseases

Procedure: Biological sampling in control patients

Interventions

Biological sampling in patients PROCEDURE

blood and bone marrow samples from patients with Acute Leulemia.

Patients with acute leukemias

Biological sampling in control patients PROCEDURE

blood and bone marrow samples from children undergoing orthopedic surgery exposing the bone marrow.(osteotomy of the pelvis).

Control group

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• for patients with AL:
• 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.
• Affiliated patient or beneficiary of a social security scheme.
• Control group patients:
• Child undergoing orthopedic surgery exposing the bone marrow (osteotomy of the pelvis).
• Aged between 1 and 15 years old.
• Having no pathology of hematological origin.
• Not having received any treatment that could interfere with the functioning of the bone marrow.
• Whose 2 parents or the holder of parental authority have signed a consent enlightened.
• Affiliated patient or beneficiary of a social security scheme.

You may not qualify if:

• for patients with AL:
• 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.
• Having received prior hematological treatments.
• Parents with physical or mental condition not allowing to understand the informed consent.
• Control group patients
• Patient under 1 year old and over 15 years old.
• Having an underlying haematological pathology.
• Absence of signature of the informed consent by the 2 parents or the holder of parental authority.
• Having received prior hematological treatments.
• Parents with physical or mental condition not allowing to understand informed consent.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

Service d'hématologie biologique-CHRU TOURS

Tours, 37044, France

NOT YET RECRUITING

Service d'onco-hématologie pédiatrique -CHRU Tours

Tours, 37044, France

RECRUITING

Service de chirurgie orthopédique pédiatrique -CHRU TOURS

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Olivier HERAULT, MD-PhD

  University Hospital of TOURS

  STUDY DIRECTOR

• Julien LEJEUNE, MD-PhD

  University Hospital of TOURS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier HERAULT, MD-PhD

CONTACT

+33(0)234378902; olivier.herault@univ-tours.fr

Wiebe de JONG, MSc

CONTACT

+33(0)247474680; w.dejong@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, interventional monocentric biological study in two parallel and controlled groups

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 30, 2023
• Study Start: October 26, 2023
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 24, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)