Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06045689
Start Date
October 5 2023
End Date
December 30 2027
Last Update
November 10 2025
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0051
Los Alamitos, California, United States, 90720-3309
2
Local Institution - 0033
New Haven, Connecticut, United States, 06510
3
Local Institution - 0055
St. Petersburg, Florida, United States, 33705
4
Local Institution - 0056
Wellington, Florida, United States, 33414