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Studying Chronic Graft-versus-Host Disease
Untitled Document
Name of the Trial
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 6.
Principal Investigator
Dr. Steven Pavletic, NCI Center for Cancer Research.
Why This Trial 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 percent
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.
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Dr. Steven Pavletic
Principal Investigator |
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 three and a half 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."
Who Can Join This Trial
Researchers will enroll 170 patients (120 adults and 50 children) diagnosed
with chronic GVHD following allogeneic HSCT. See the list of eligibility
criteria 7.
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.
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