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Blood test may reveal why some MDS patients feel worn out on luspatercept

NCT ID NCT07830004

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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