Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath,
Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal
transplant. Seventy-five subjects receiving primary or repeat intestine transplantation will
be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute
cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of
subjects with steroid-free Tacrolimus at whole blood concentrations < 10 ng/ml. Secondary
endpoints include a) incidence and severity of opportunistic infections (CMV and EBV),
post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of
non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d)
longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses
(MLR), to identify the time at which it decreases to a level less than third-party-specific
alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and
non-rejection-specific genes and f) characterization of whole genome mutations, which show
differences in parent-to-child transmission between rejectors and non-rejectors. This will
identify rejection- and non-rejection-specific genes bearing genetic variants, which might
impact on gene function, and complement candidate gene identification efforts based on SNP
transmission.