Clinical trial · Observational
First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms
A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care. The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes. Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Neoplasms | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luspatercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- First-Line Luspatercept
- description
- Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
- interventionNames
- Drug: Luspatercept
Primary outcomes (1)
- measure
- Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
- timeFrame
- Up to Week 24
Secondary outcomes (14)
- measure
- Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
- timeFrame
- Up to Week 48
- measure
- Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available