ABSTRACT
TEAMMATE is a multicenter randomized clinical trial of a novel immunosuppressive therapy that is studing children who have undergone recent heart transplantation. The primary goal is to determine whether a new rejection treatment (everolimus and low-dose tacrolimus) can reduce or prevent complications of transplant, including rejection, coronary artery disease, and kidney disease, when compared to usual care (tacrolimus and mycophenolate mofetil). The secondary goal is to acquire FDA approval of the first immunosuppression regimen for pediatric heart transplantation. The primary trial endpoint is a validated surrogate measurethe major adverse transplant event (MATE) scorewhich efficiently predicts long-term survival, and that has been accepted by the FDA (IND# 127980). The trial is being conducted at 25 centers, with leadership at Boston Childrens Hospital (Data Coordinating Center) and Stanford University (Clinical Coordinating Center). At the time of this annual report, enrollment is complete and the target has been met, with 211 patients randomized (60 in the last year). Each participant will be followed for 30 months. Additional accomplishments in Year 03 include one in-person Protocol Certification Training;successful execution of one Data and Safety Monitoring Board meeting;national presentation of research on everolimus dosing, baseline characteristics and recruitment strategies;and the continuation of endpoint adjudication and regulatory/data audit site visits.