Blood test may reveal why some MDS patients feel worn out on luspatercept
NCT ID NCT07830004
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are studying blood samples from 150 adults with lower-risk myelodysplastic syndromes (MDS) who receive luspatercept, a drug that boosts red blood cell production. The goal is to find metabolites and other biomarkers linked to fatigue, a common side effect of the treatment. Participants give blood and answer fatigue questionnaires over six months. The study does not test a new treatment; it looks for biological clues that might explain why some patients feel exhausted and others do not.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- luspatercept, a drug that helps the body make red blood cells
- What this could lead to
- If researchers find biomarkers tied to fatigue, doctors could one day predict who is likely to feel exhausted on luspatercept and adjust care earlier.
- What could go wrong
- This is an observational study, so it can only find links, not prove cause. Fatigue has many sources, and a biomarker pattern in 150 people may not hold up in larger groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. Signed Written Informed Consent 2. Participants must be ≥ 18 years of age 3. Type of Participant and Target Disease Characteristics: Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification 4. IPSS-R : very low, low, or intermediate-risk disease 5. Less than 5% blasts (\< 5%) (in bone marrow and \< 1% PB blasts) 6. Performance status: Eastern (ECOG) score of 0, 1, or 2 7. Anemic patients with Hb ≤10g/dL 8. First line therapy by luspatercept for lower risk MDS RS+ and MDS-RS- patients 9. 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 10. Patient or his entourage having a smartphone to load the application for Fidelio ( the chatbot) 11. Affiliated to SS Exclusion critéria: 1. Higher risk MDS, del 5q syndrome, MDS-RS-T, MD- CMML 2. Participant which has known clinically significant anaemia due to iron, vitamin B12, or folate deficiencies, iron deficiency anaemia or autoimmune haemolytic anaemia 3. Prior allogeneic or autologous stem cell transplant 4. Use of any of the following within 2-weeks prior to treatment: Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days 5. Pregnancy 6. Psychiatric contraindications 7. Protected people according to articles L1121-5 à L1121-8 of CSP
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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