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SAMA Regimen for aGVHD Prophylaxis in CNI-Intolerant Haplo-HSCT
NCT06279494Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Mar 2024
- Primary completion
- Jun 2024
- Sponsor
- Peking University People's Hospital
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 2, open-label, single-arm trial of sirolimus in Acute Graft-Versus-Host Disease (aGvHD), sponsored by Peking University People's Hospital. Primary endpoint: Incidence of Grade 2-4 Acute Graft-versus-host Disease at 100 days. Planned start Mar 2024; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sirolimus+Abatacept+MMF+ATG
Sirolimus, Abatacept, Mycophenolate Mofetil, and ATG combination regimen
03
Who it enrols
Patients receiving first-time haplo-HSCT who are intolerant or have contraindications to Calcineurin Inhibitors (CNI), including those with GFR 60-89 ml/min/1.73m2 or prior CNI toxicity.
04
Endpoints
Primary
Incidence of Grade 2-4 Acute Graft-versus-host Disease
Secondary
Incidence of Chronic Graft-versus-host Disease
Incidence of Thrombotic Microangiopathy
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