Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
The primary goal of the study is to determine the incidence and severity of acute Graft
versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor
Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the
combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will
determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets
(engraftment), determining the occurrence of opportunistic infections, defined as infection
that occurs in people with weakened immune systems and caused by organisms that do not
normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral
infections), estimating the incidence of chronic GVHD at two years and the overall and
disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at
various points after transplant.