drugset / Trial / NCT05181735
Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA
Phase 1/2
Recruiting
150 enrolled
Groupe Francophone des Myelodysplasies
Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA
Timeline
- Start
- 2022-05-18
- Primary completion
- 2028-12-19
- Completion
- 2029-06-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luspatercept | Protein / enzyme biologic | 0.8 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1.33 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1.75 mg/kg | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 30000 iu | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 60000 iu | Subcutaneous |