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Completed

NCT Number: NCT04803721

Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments that justify new therapeutic approaches. Various studies have described the potential involvement of both immune compartment and cellular metabolism in the pathophysiology of MDS. The aim of this study is to determine the specific immune and metabolic profiles of the different classes of MDS and to identify predictive markers of progression/survival/response to therapy.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IUCT-Oncopole University Hospital

Toulouse, 31500, France

About this study

Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments. It is the most frequent haematological disorder after the age of 65. Different approaches targeting the immune compartment have been developed but preliminary results seem to show variable response rates to these therapeutic highlighting the heterogeneity of MDS and the need to identify detailed immune profiles that are predictive of disease progression and can help in treatment choices. It therefore seems essential to complement the knowledge of immune profiles with an understanding of the metabolic profiles of MDS patients, as well as the links between these profiles and changes associated with progression and/or treatment resistance, in order to consider new therapeutic pathways.

Fresh samples from patients with MDS will be used to perform flow cytometry mapping of immune populations, T-cell and blast cell metabolism. Subsequently, a study of energy metabolism will be conducted using an extracellular flow analyzer and a sensitivity test for certain molecules targeting metabolic pathways. If possible, samples will be taken at different times during the course of treatment, according to the therapeutic protocols: diagnosis, progression/transformation, during azacitidine treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients:
  • Patient over 18 years of age with a myelodysplastic syndrome (WHO 2016 classification) of low risk (LR=IPSS-R<4.5) or high risk (HR=IPSS-R>4.5);
  • Patient naïve to specific treatment of MDS;
  • Patient who expressed no opposition to participating in the study. ;
  • Patient affiliated with the social security system.
  • Control:
  • over 18 years of age,
  • Sample from blood donation (regardless of age) Or Patient >60 years old, see at the geriatrics platform of the hospital la Grave (CHU of Toulouse),
  • having expressed his non opposition to participate in the study

Exclusion criteria

  • Patients:
  • Myeloid disease other than MDS (including chronic myelomonocytic leukemia and MDS/SMP) ;
  • Ongoing treatments for MDS (excluding erythropoietin, granulocyte colony-stimulating factor and transfusions) ;
  • Medical conditions that may interfere with immune system testing: active cancer, active autoimmune disease, inflammatory conditions, immunosuppressive therapy. ; * Pregnant or breastfeeding women ; Patient's refusal ;
  • Person benefiting from a system of protection for adults (including guardianship, curators and safeguarding of justice)
  • Control:
  • Medical conditions that may interfere with immune system testing: active cancer, active autoimmune disease, inflammatory conditions, immunosuppressive therapy. ; * Pregnant or breastfeeding women ;
  • Patient's refusal ;
  • Person benefiting from a system of protection for adults (including guardianship, curators and safeguarding of justice)

Treatment and study plan

Primary outcomes

  1. Immune and metabolic profiles will be evaluated by immunophenotyping

    Time frame: Day 0

    phenotypic study of one or more leukocyte sub-populations by flow cytometry

Secondary outcomes

  1. Identification of time to progression/transformation and time to death

    Time frame: Day 0 and through study completion, an average of 1 year

    Clinical and biological data will be collected during follow up

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes: Involvement in Leukemia Transformation and Therapeutic Targeting

Acronym: IMET-MDS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2021
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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