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A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India

StatusActive, Not Recruiting
PhasePhase 4
Started2023-06-05
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status, IPDSharing v11
Re-verified, no change to tracked fields
2025-10-15
Study Status, Study Design v10
Primary completion date2026-04-16→2028-12-16
Completion date2026-04-16→2028-12-16
Enrollment target60→85
2025-04-15
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-02-17→2026-04-16
Completion date2026-04-13→2026-04-16
Study sites13→9
2024-11-15
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 13 sites
2024-08-26
Study Status, Contacts/Locations v7
Primary completion date2026-04-13→2026-02-17
Study sitescontacts updated at 1 of 13 sites
Show 6 earlier versions
2024-06-10
Study Status, Contacts/Locations v6
Study sites13 entries, revised
LocalAll InstitutionIndia -Institute 0001of Medical Sciences
2024-05-01
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v5
Primary completion date2026-02-17→2026-04-13
Completion date2026-02-17→2026-04-13
Eligibility criteria+164 characters
[...] erficial venous thrombosis and chronic aspirin are allowed. Cytotoxic agents or immunosuppressants or immunomodulatory drugs (IMiDs) ≤ 28 days prior to enrollment (ie, antithymocite globulin or cyclosporine or thalidomide). MDS-RS Cohort MDS associated with del 5q cytogenetic abnorma [...]
Secondary endpoints5 entries, revised
[...] from baseline) with a reduction of at least 2 red cell units compared to the 12-week interval prior to enrollment β-Thal Cohort: Percentage of participants who achieved RBC [...] -week interval with a reduction of at least 2 red cell units compared to the 12-week interval prior to enrollment
2024-02-26
Study Status, Contacts/Locations, References v4
Study sites12→13
2023-11-01
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 12 sites
2023-10-11
Study Status, Contacts/Locations v2
Study sites3→12
2023-09-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-08→confirmed 2023-06-05
Study sites0→3
2023-05-26
Original filing
The purpose of this study is to evaluate the safety and effectiveness of luspatercept in participants who require regular blood cell transfusions due to b-thalassemia and myelodysplastic syndromes in India
Trial Details
NCT Number NCT05891249
Lead Sponsor Bristol-Myers Squibb
Conditions Anemia
Enrollment 85 participants
Start Date 2023-06-05
Primary Completion 2028-12-16 (estimated)
Study Completion 2028-12-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-31