Real-World data reveals Luspatercept's impact on MDS patients
NCT ID NCT06851065
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked back at medical records of 418 patients with lower-risk myelodysplastic syndromes (MDS) who had not previously used erythropoiesis-stimulating agents (ESAs). Researchers examined how luspatercept was used in everyday practice, including dosing, treatment changes, and outcomes like blood transfusion needs and disease progression. The goal was to understand the real-world effectiveness of luspatercept in this patient group.
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 results are positive, this could help doctors understand how well luspatercept works in everyday practice for MDS patients.
- What could go wrong
- This is a retrospective chart review, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients.
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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418 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
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Mar 2025
- Lead sponsor
-
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
The study population will include adults in the United States with a clinician-confirmed diagnosis of primary or secondary lower-risk myelodysplastic syndromes (LR-MDS) who initiated first-line luspatercept treatment on or after LR-MDS diagnosis date between 28 August 2023 to 31 July 2024
- 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: * Had a documented diagnosis of primary or secondary myelodysplastic syndromes (MDS) * MDS diagnosis confirmed through bone marrow testing on (or 30 days prior to) MDS diagnosis date or within 1 year of MDS diagnosis date * Had a documented determination of Lower Risk (LR)-MDS as measured by International Prognostic Scoring System (IPSS) or its revised version (IPSS-R) at or before index treatment (i.e., first-line luspatercept or first-line erythropoiesis-stimulating agents (ESA)) initiation * IPSS risk level: low, intermediate-1 (level-1 risk) * IPSS-R risk level: very low, low, intermediate * Received luspatercept as the first-line treatment for anemia any time from 28 August 2023 to 31 July 2024 (Cohort 1) * Receipt of combination therapy with ESAs and/or granulocyte colony-stimulating factors (G-CSFs) will be allowed OR * Received ESA as the first-line treatment for anemia any time from 28 August 2023 to 31 July 2024 (Cohort 2) * Was aged 18 years or older at the time of initial diagnosis of MDS * Known vital status (i.e., living, or deceased) at the time of record abstraction. * Records for patients who are dead or alive will be eligible * Complete medical record covering relevant past medical history, diagnosis of LR-MDS, treatment, laboratory assessments, red-blood cell (RBC) transfusions, and regular monitoring for LR-MDS, including any transfer record from other physicians/facilities (if applicable) is available to the abstracting physician for data abstraction Exclusion Criteria: * Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis * Received previous treatment with hypomethylating agents, disease-modifying agents (including lenalidomide), other immunosuppressants/immunomodulatory agents, or other MDS-directed chemotherapy * Received stem cell transplant prior to index treatment initiation * Participated in a clinical trial for the treatment of MDS before or while on index treatment (i.e., clinical trial participation after first-line luspatercept or ESA treatment discontinuation will be allowed) * Had evidence of other malignant neoplasms in the 12 months prior to diagnosis of MDS, except basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b) * Patients for whom this information is not available (i.e., "unknown") will be included in the study * For Cohort 1 (i.e., first-line luspatercept treatment), receipt of combination therapy with hypomethylating agents, lenalidomide, other immunosuppressants/ immunomodulatory agents, or other MDS-directed chemotherapy * For Cohort 2 (i.e., first-line ESA treatment), receipt of combination therapy with hypomethylating agents, lenalidomide, luspatercept, other immunosuppressants/ immunomodulatory agents, or other MDS-directed chemotherapy
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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.
Contacts and locations
Locations
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RTI Health Solutions
Raleigh, North Carolina, 27709-2194, United States
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