Randomized Study: Standard of Care With or Without Atorvastatin for Prevention of GVHD for Matched Unrelated Donor BMT
Status:
Withdrawn
Trial end date:
2021-02-28
Target enrollment:
Participant gender:
Summary
Chronic Graft Versus Host Disease (GVHD) is one of the most challenging complications in long
term survivors of allogeneic stem cell transplantation. As the number of allogeneic stem cell
transplantations rises annually, the incidence of chronic GVHD rates have also increased due
to a variety of factors including but not limited to increasing use of peripheral blood stem
cell (PBSC) grafts, increasing age of both donors and recipients, and increased use of
matched unrelated donors. One study showed much lower than traditional acute GHVD rate and
chronic GHVD which is similar with historical rates when atorvastatin was administered
prophylactically to both the donors as well as recipients of matched related allogeneic stem
cell transplantation, lead to the interest in further examining the role of Atorvastatin in
relation to the development of GVHD. The investigator hypothesize that the administration of
atorvastatin in recipients of matched unrelated allogeneic stem cell transplantation, a group
with known higher incidence of chronic GHVD, would be a safe and effective method to reduce
the incidence of chronic GVHD. Matched related allogeneic stem cell transplantation
recipients will not be included in this study due to their significantly lower GVHD rates.
The definition and monitoring of our primary endpoint of GVHD is well established in clinical
trials in allogeneic stem cell transplantations and the investiagor will utilize the National
Institutes of Health (NIH) Staging System for the diagnosis and severity assessment of
chronic GVHD as well the recommendations from the NIH Consensus Conference for the conduct of
clinical trials in chronic GVHD.
Several secondary endpoints will be examined as defined below and include standard
complementary data in the examination of clinical trials in chronic GVHD again as laid out by
the NIH Consensus Conference for conduct of clinical trials in chronic GHVD.