Conditions: Graft vs Host Disease
Keywords: HSCT HPC HCT BMT lipitor atorvastatin HMG-CoA Reductase Inhibitor Hematopoietic stem cell transplant allogeneic transplant GVHD graft-versus-host-disease Graft vs Host Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
Atorvastatin for prevention of acute GVHD

Detailed description:
This is a phase II study of atorvastatin for the prophylaxis of acute GVHD in patients undergoing matched-sibling allogeneic HSCT. This study will explore a two-pronged acute GVHD prophylaxis strategy, consisting of pre-treating consenting sibling donors with atorvastatin before stem cell collection, followed by the addition of atorvastatin to methotrexate/tacrolimus-based GVHD prophylaxis.

Arms:
arm 1: Atorvastatin calcium (Lipitor) will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD. This is the experimental arm for outcome measures. arm 2: Sibling donors will start taking Atorvastatin calcium (Lipitor) orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.

Interventions: intervention 1: Atorvastatin calcium (Lipitor)
Intervention descriptions: intervention 1: 40 mg PO daily

Protocol document: