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Atorvastatin for prophylaxis of acute GVHD in HSCT
NCT01175148Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2010
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- West Virginia University
- Modality
- Small Molecules
- Drugs
- atorvastatin
- Conditions
- graft-versus-host disease (GVHD)
01
Overview
Phase 2, open-label trial of atorvastatin in graft-versus-host disease (GVHD) (2 arms), sponsored by West Virginia University. Primary endpoint: Cumulative Incidence of Grade 2 to 4 Acute Graft vs Host Disease (GVHD) at Day 100 Post Transplant. Started Jul 2010; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Recipient
Patients undergoing HSCT receiving Atorvastatin prophylaxis
Donor
Sibling donors receiving Atorvastatin conditioning
03
Who it enrols
Patients aged 18-75 with hematological malignancy or bone marrow failure suitable for matched sibling allogeneic HSCT. Donors must be >=18 years. Patients must have adequate organ function and no active infection.
04
Endpoints
Primary
Cumulative Incidence of Grade 2 to 4 Acute Graft vs Host Disease (GVHD) at Day 100 Post Transplant
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