A new hope for MDS patients: could this drug cut blood transfusions?
NCT ID NCT07752121
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This study looks at whether luspatercept, a drug given as first-line treatment, can help adults with low-risk myelodysplastic neoplasms (MDS) who need regular red blood cell transfusions. Researchers will follow about 190 participants for up to 2 years to see how often they achieve periods without transfusions, changes in hemoglobin levels, and quality of life. The study observes routine medical care in Germany, providing real-world insights into the drug's effectiveness and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- luspatercept
- What this could lead to
- If successful, this could show that luspatercept helps people with low-risk MDS go longer without needing blood transfusions, improving their quality of life.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by other factors. The drug may not work for everyone, and side effects are possible.
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.
- Participants
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
- 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: * Males and females ≥18 years of age at enrollment. * Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease. * Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation. * First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation * Provision of written informed consent. Exclusion Criteria: * Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). * Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol). Patients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment. • Concurrent malignancy requiring treatment.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie
Mainz, Germany
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