A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: October 15, 2023
End Date: December 30, 2027
First line of the email MUST contain the NCT# and Site#
Inclusion Criteria:
- Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
- Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
- Participant must have red blood cell transfusions according to study criteria.
Exclusion Criteria:
- Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
- Participant has had a prior allogeneic or autologous stem cell transplant.
- Participant has known history or diagnosis of AML.
- Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply
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Conditions:
- Preleukemia
- Myelodysplastic Syndromes
- Syndrome