Clinical Trial: Atorvastatin for the Prophylaxis of Acute Graft-versus-host Disease in Patients Undergoing Matched Sibling Allogeneic Transplantation
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study Evaluating the Safety and Efficacy of Atorvastatin for the Prophylaxis of Acute Graft-versus-host Disease in Patients Undergoing Matched Sibling Hematopoiet
Brief Summary: Atorvastatin for prevention of acute GVHD
Detailed Summary: 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.
Sponsor: Mehdi Hamadani
Current Primary Outcome:
- Determine the efficacy of an atorvastatin/tacrolimus/methotrexate regimen in preventing grade II-IV acute GVHD in patients undergoing matched-sibling allogeneic hematopoietic stem cell transplantation (HSCT) [ Time Frame: 100 days ]
- Assess the safety of an atorvastatin/tacrolimus/methotrexate regimen in patients undergoing matched-sibling allogeneic HSCT. [ Time Frame: One year ]
- Assess the safety of an atorvastatin in sibling HSCT donors. [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess rates of chronic GVHD. [ Time Frame: One year ]
- To assess non-relapse mortality at 100 days post-HSCT. [ Time Frame: 100 days post-HSCT ]
Original Secondary Outcome: Same as current
Information By: West Virginia University
Dates:
Date Received: August 2, 2010
Date Started: July 2010
Date Completion: December 2014
Last Updated: January 11, 2013
Last Verified: January 2013
