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Sirolimus +/- Cyclosporin A in Refractory/Intolerant Aplastic Anemia
NCT06802055Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Jan 2026
- Countries
- 1
- Sponsor
- Peking Union Medical College Hospital
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- aplastic anemia
01
Overview
Phase 2, randomised, open-label trial of sirolimus in aplastic anemia (2 arms), sponsored by Peking Union Medical College Hospital. Primary endpoint: Overall Response Rate at 3 months. Started Jan 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sirolimus + cyclosporin A
Sirolimus combined with Cyclosporin A
Sirolimus
Sirolimus monotherapy
03
Endpoints
Primary
Overall Response Rate
Secondary
Overall Response Rate
Changes in Hemoglobin in the Absence of Red Blood Cells Transfusion
Changes in Platelet in the Absence of Platelet Transfusion
Duration of Hematologic Response
Percentage of patients with clonal evolution
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