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Luspatercept in Low-Risk Myelodysplastic Syndrome Requiring RBC Transfusions
NCT06045689Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2023
- Primary completion
- Oct 2025
- Countries
- 9
- Sponsor
- Bristol Myers Squibb
- Modality
- Fc-Fusion Proteins
- Drugs
- luspatercept
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 3, open-label trial of luspatercept in myelodysplastic syndrome (MDS) (2 cohorts), sponsored by Bristol Myers Squibb. Primary endpoint: Red blood cell transfusion independence for 8 weeks with a simultaneous mean hemoglobin increase of >= 1 g/dL at 24 weeks. Started Oct 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort 1: ESA naïve
Participants who are naïve to erythropoiesis-stimulating agents receiving Luspatercept
Cohort 2: ESA relapsed or refractory
Participants who are relapsed or refractory to erythropoiesis-stimulating agents receiving Luspatercept
03
Who it enrols
Patients with very low-, low-, or intermediate-risk MDS requiring RBC transfusions, with ECOG 0-2, excluding those with anemia from other causes, prior stem cell transplant, history of AML, or uncontrolled hypertension.
04
Endpoints
Primary
Red blood cell transfusion independence for 8 weeks with a simultaneous mean hemoglobin increase of >= 1 g/dL
Secondary
Mean change in total RBC units transfused
Time from first dose to first onset of RBC-TI >= 8-, 12-, and 16-weeks
RBC-TI over any consecutive 8-week period
Maximum duration of RBC-TI for participants who achieve RBC TI >= 8- and 16-week period
RBC-TI over any consecutive 12-, 16-, and 24-week periods
Increase from baseline in mean hemoglobin values of >= 1.0 g/dL over any consecutive 8-week period
Increase from baseline in Hb values of >= 1.0 g/dL over any consecutive 16-week period
Increase from baseline in Hb values of >= 1.5 g/dL over any consecutive 8-, and 16-week periods
05
Results
Primary endpoints met
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