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NCT07830004Not yet recruitingPhase 4

Plasmatic Biomarkers Associated With Short-term Luspatercept Treatment of Lower Risk Myelodysplastic Syndromes (MDS) Patients

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

Our project aims to identify metabolites and biomarkers associated with luspatercept-related asthenia in a prospective French study of low-risk MDS patients treated per EMA guidelines. This is a prospective cohort of patients with MDS treated with luspatercept. The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
150 (estimated)
First submitted
4 Sept 2026
Start date
1 Nov 2026
Primary completion date
31 May 2031
Lead sponsor
University Hospital, Grenoble
NCT number
NCT07830004

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 150
  • From 1 Nov 2026 to the primary completion date, 31 May 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Signed Written Informed Consent
  • Participants must be ≥ 18 years of age
  • Type of Participant and Target Disease Characteristics:
    • Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification
  • IPSS-R : very low, low, or intermediate-risk disease
  • Less than 5% blasts (\< 5%) (in bone marrow and \< 1% PB blasts)
  • Performance status: Eastern (ECOG) score of 0, 1, or 2
  • Anemic patients with Hb ≤10g/dL
  • First line therapy by luspatercept for lower risk MDS RS+ and MDS-RS- patients
  • Or Second line therapy by luspatercept for MDS-RS+ refractory or intolerant to prior ESA treatment, as defined by any one of the following:
    • Refractory to prior ESA treatment: documentation of nonresponse or response that was no longer maintained to prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF).
    • Intolerant to prior ESA treatment: Documentation of discontinuation of prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE
  • Patient or his entourage having a smartphone to load the application for Fidelio ( the chatbot)
  • Affiliated to SS
    • Exclusion critéria:
  • Higher risk MDS, del 5q syndrome, MDS-RS-T, MD- CMML
  • Participant which has known clinically significant anaemia due to iron, vitamin B12, or folate deficiencies, iron deficiency anaemia or autoimmune haemolytic anaemia
  • Prior allogeneic or autologous stem cell transplant
  • Use of any of the following within 2-weeks prior to treatment:
    • Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days
  • Pregnancy
  • Psychiatric contraindications
  • Protected people according to articles L1121-5 à L1121-8 of CSP

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.