Name of the Study
Natural History Study of Clinical and Biological Factors in Patients with Chronic Graft-versus-Host Disease After Prior Allogeneic Hematopoietic Stem Cell Transplantation (NCI-04-C-0281). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0281.

Principal Investigator
Dr. Steven Pavletic, NCI Center for Cancer Research

Why This Study Is Important
About 7,000 people undergo a procedure called allogeneic hematopoietic stem cell transplantation (HSCT) each year in the United States, usually as a treatment for blood cancers. In allogeneic HSCT, the patient receives healthy blood-forming stem cells from a genetically similar, but not identical, donor, such as a sibling or parent.

Because the immune system works to reject cells it sees as foreign, allogeneic transplants carry the risk of graft-versus-host disease (GVHD). GVHD occurs when donor lymphocytes (disease-fighting white blood cells) attack the patient's organs after HSCT or bone marrow transplantation. GVHD that occurs more than 100 days after a transplant is called chronic GVHD. Approximately 30 to 50 percent of allogeneic HSCT patients experience this late complication of therapy, which may seriously affect their quality of life and can be life threatening.

In this study, researchers are interested in determining the natural history of chronic GVHD and assessing biological factors that may predict outcomes associated with it.

"Patients with chronic GVHD who are enrolled in this study will come to the NIH Clinical Center to be evaluated by a multidisciplinary research team for 3½ days," said Dr. Pavletic. "Their participation will help us to better understand the biological and clinical components of chronic GVHD, and hopefully allow us to develop new therapies and assessment tools for patients with chronic GVHD.

"Additionally, participating patients may be screened for eligibility for future therapeutic trials to treat this condition," he noted.

Who Can Join This Study
Researchers will enroll 170 patients (120 adults and 50 children) diagnosed with chronic GVHD following allogeneic HSCT. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NCI-04-C-0281.

Study Site and Contact Information
The trial is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center toll free at 1-888-NCI-1937. The call is confidential.