Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients With Chronic Graft-Versus-Host Disease
Protocol # 04-C-0281
- Why is this trial important?
- Who is eligible for this trial?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
This study will examine the natural history of chronic graft-versus-host disease, a complication of blood or bone marrow stem cell transplant treatments. Patients with cancers of the blood and immune system can sometimes benefit greatly from, and even be cured by, transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to producing new bone marrow and restoring normal blood production and immunity, the donated cells fight any residual tumor cells that might have remained in the body. However, donated immune system cells called T cells sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD). Chronic GVHD (cGVHD) is one of the most serious complications of stem cell transplants. It can affect almost any part of the body, especially the skin, mouth, liver, gut, and eyes. A better understanding of cGVHD may lead to improved treatments.
Who is eligible for this trial? (PDQ)
- Age 1-75 years
- Life expectancy of greater than 3 months
- Recipient of an allogeneic (related or unrelated donor) stem cell transplant
- Diagnosed with chronic graft-versus-host disease or referred by physician for the evaluation of possible chronic-graft-versus-host disease
What is the treatment plan? (PDQ)
- Trial participants will come to the NIH in Bethesda, MD for a comprehensive, multidisciplinary evaluation lasting 4 days
- Participants will have blood testing, organ evaluation, and comprehensive consults with multidisciplinary team members
- Recommendations will be made to participant's referring physician for GVHD treatment options
What is the frequency and duration of the visits?
All evaluations are on the outpatient basis. Patients are required to spend about 3 days at the NIH clinical center to complete their evaluations. No follow-up visits are mandated by this protocol.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Steven Pavletic received his M.D. from the University of Zagreb School of Medicine in Croatia in 1979, followed by his 1992 completion of clinical fellowship in Bone Marrow Transplantation from Fred Hutchinson Cancer Research Center and University of Washington Medical School in Seattle, Washington. In 1995 he completed his internal medicine residency from the University of Nebraska Medical Center, Omaha, Nebraska. Dr. Pavletic completed his Hematology and Oncology fellowship from the University of Nebraska medical center in Omaha, Nebraska in June 1997.
In 2002, Dr. Pavletic received an adjunct appointment at the National Institute for Arthritis and Musculoskeletal and Skin Diseases in Bethesda, Maryland and is the head of the Graft-versus-Host and Autoimmunity Unit of the Experimental Transplantation and Immunology Branch.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Experimental Transplantation and Immunology Branch
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Steven Pavletic, M.D., M.S.
Principal Investigator
Phone: 301-402-4899
pavletis@mail.nih.gov
Bazetta (Zetta) Blacklock, R.N., B.S., B.S.N.
Transplant Coordinator
Phone: 301-594-2056
Fax: 301-435-6830
bblacklock@mail.nih.gov
Where can additional information be found?
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