Phase 2
N=60
Atorvastatin for the Prophylaxis of Acute GVHD in Patients Undergoing Matched Sibling Allogeneic Transplantation
Graft vs Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT01175148 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients — 3.3 percentage of participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin calcium (Lipitor) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients |
3.3 | <0.05 sig |
Summary
Atorvastatin for prevention of acute GVHD
Eligibility Criteria
DONOR ELIGIBILITY CRITERIA:
- Donors must be ≥18 years of age, and willing/able to provide informed consent.
- Female donors of child-bearing potential should have a negative pregnancy test, and must be not be breast feeding.
- Adequate hepatic function with bilirubin, AST and ALT 18 and ≤ 50 years will be eligible for myeloablative conditioning (MAC), while patients > 50 years of age, or those with previous history of autologous transplantation, high hematopoietic cell transplant comorbidity index (HCT-CI) score (>2), and baseline diagnosis of hodgkin's lymphoma, chronic lymphocytic leukemia and follicular lymphoma will be suitable for reduced intensity conditioning (RIC) transplantation (however intensity of conditioning regimen will remain at the discretion of treating physician).
- All patients must have at least one suitable HLA-matched sibling donor according to transplant center's guidelines (for selection of appropriate sibling donor).
- Patient must provide informed consent.
- Left ventricular ejection fraction > 40%. No uncontrolled arrhythmias or uncontrolled New York Heart Association class III-IV heart failure.
- Bilirubin 70.
- A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted.
- Patients with positive HIV serology are not eligible.
- No evidence of active uncontrolled bacterial, viral or fungal infection at the time of transplant conditioning.
- Patients with history of intolerance or allergic reactions with atorvastatin will not be eligible.
- Patients who have previously been taking atorvastatin or any other statin drug will be eligible as long as there is no contraindication to switch to atorvastatin (40mg/day) in the opinion of the treating physician.
- Patients undergoing a T-cell depleted allogeneic transplantation will not be eligible.
- Patients receiving conditioning regimens containing antithymocyte globulin, and/or campath will not be eligible.
Data sourced from ClinicalTrials.gov (NCT01175148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.