Trial Information

Summary: BMT CTN 0402: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as Graft-Versus-Host-Disease (GVHD)Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation

Donor - You have/your child has been asked to participate in this research study because you have/your child has agreed to donate peripheral blood stem cells (PBSC, immature cells that can become blood cells) to your/your child’s brother or sister.  The purpose of this study is to learn about genetic factors that may have an influence on the risks of Graft-versus-Host Disease (GVHD) and long-term outcome after transplant of cells from a donor.  Your participation in this study is expected to last approximately 15 minutes, the amount of time required for one blood draw.

Recipient - You have/your child has been asked to participate in this research study because you have/your child has a disease that can be treated by a peripheral blood stem cell (PBSC, immature cells that can become blood cells) transplant and you have/your child has a tissue-matched brother or sister who has agreed to be your/your child’s donor.  The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD: A) sirolimus and tacrolimus (experimental treatment) and B) methotrexate and tacrolimus (standard treatment).  Doctors also want to know how long it takes for donated cells to start growing in recipients with combination A and with combination B.  Your/your child’s participation in this study is expected to last about 3 months for treatment and a minimum of 2 years for follow-up.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: September 2, 2008 at 1:51:49 PM