Exploring the Bone Marrow Environment in Childhood Leukemia

Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant

This study is trying to understand how the bone marrow environment affects treatment resistance in children with leukemia to find better ways to help them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Year to 15 Years
• Sex: All
• Sponsor: University Hospital, Tours (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Tours and 2 other locations)
• Trial ID: NCT05792007 on ClinicalTrials.gov

What this trial studies

This study investigates the role of the bone marrow microenvironment in acute childhood leukemia, focusing on how it may contribute to treatment resistance. It aims to understand the interactions between leukemia cells and mesenchymal stromal cells (MSCs), particularly regarding energy metabolism. By analyzing biological samples from children diagnosed with acute lymphoblastic or myeloblastic leukemia, as well as control patients undergoing orthopedic surgery, the study seeks to uncover mechanisms that could lead to improved treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include children aged 1 to 15 years diagnosed with acute lymphoblastic or myeloblastic leukemia who have not received prior treatment.

Not a fit: Patients outside the age range of 1 to 15 years or those with hematological conditions unrelated to leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to better understanding and treatment options for children with acute leukemia, potentially reducing relapse rates.

How similar studies have performed: While there is limited research on the microenvironment in childhood leukemia, studies in adult leukemia have shown promising results, indicating potential for this approach.

Eligibility criteria

Inclusion Criteria:

* for patients with AL:

  1. Child with acute lymphoblastic or myeloblastic leukemia at diagnosis
  2. Not having received prior hematological treatment
  3. Aged 1 to 15 years old
  4. Whose 2 parents, or the holder of parental authority, have signed a consent enlightened.
  5. Affiliated patient or beneficiary of a social security scheme.
* Control group patients:

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

Exclusion Criteria:

* for patients with AL:

  1. Patient under 1 year old and over 15 years old.
  2. Contraindication to myelogram.
  3. Absence of signature of the informed consent by the 2 parents or the holder of parental authority.
  4. Patients with relapsed acute lymphoblastic or myeloblastic leukemia.
  5. Having received prior hematological treatments.
  6. Parents with physical or mental condition not allowing to understand the informed consent.
* Control group patients

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

Where this trial is running

Tours and 2 other locations

• Service d'hématologie biologique-CHRU TOURS — Tours, France (Not_yet_recruiting)
• Service d'onco-hématologie pédiatrique -CHRU Tours — Tours, France (Recruiting)
• Service de chirurgie orthopédique pédiatrique -CHRU TOURS — Tours, France (Recruiting)

Study contacts

• Principal investigator: Julien LEJEUNE, MD-PhD — University Hospital of TOURS
• Study coordinator: Olivier HERAULT, MD-PhD

Conditions Acute Lymphoid Leukemia; Acute Myeloid Leukemia in Children