The data and safety monitoring plan for the study has been approved by the NINR Data and Safety Monitoring Board. The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Recruitment is scheduled to start October 2007 at the NIH Clinical Center. In addition to the patient population provided by Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, cGVHD patients will be referred through the weekly National Cancer Institute (NCI) sponsored cGVHD Clinic at the NIH Clinical Center, under the auspices of the NCI-sponsored cGVHD natural history protocol """"""""Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients with cGVHD"""""""" (04-C-0281). Topical thalidomide is prepared by the Pharmaceutical Development Service, Clinical Center, NIH.
