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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Specified dose on specified days
Local Institution - 0002
Ahmedabad, Gujarat, India
Local Institution - 0001
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0007
Kolkata, West Bengal, India
Local Institution - 0005
Assam, India
β-Thal Cohort: Number of participants with treatment-related adverse events (AEs) of grade 3 or higher
Time frame: Up to 57 weeks
MDS-Ring Sideroblasts (RS) Cohort: Number of participants with treatment-related AEs of grade 3 or higher
Time frame: Up to 54 weeks
β-Thal Cohort: Percentage of participants who achieved red blood cell (RBC) transfusion burden reduction (≥ 33% reduction from baseline) with a reduction of at least 2 red cell units compared to the 12-week interval prior to enrollment
Time frame: Week 13 to week 24
β-Thal Cohort: Percentage of participants who achieved RBC transfusion burden reduction of at least 33% from baseline during any 12-week interval with a reduction of at least 2 red cell units compared to the 12-week interval prior to enrollment
Time frame: Up to 57 weeks
MDS-RS Cohort: Percentage of participants who achieved RBC-TI during any consecutive 56-day period
Time frame: Week 1 to week 24
β-Thal Cohort: Number of participants with treatment-related AEs
Time frame: Up to 57 weeks
MDS-RS Cohort: Number of participants with treatment-related AEs
Time frame: Up to 54 weeks
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Local Institution - 0003
Bangalore, India
Local Institution - 0004
Chandigarh, India
Local Institution - 0010
Delhi, India
Local Institution - 0006
Hyderabad, India
Local Institution - 0008
Mumbai, India