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Protocol Number:
04-C-0281
- Title:
Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients with Chronic Graft-Versus-Host Disease
- Number:
04-C-0281
- Summary:
Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival. Each year about 7000 patients receive allogeneic hematopoietic stem cell transplant (alloHSCT) in North America and about 50% of patients who are transplanted develop cGVHD. Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties. There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation.
The primary objective of this protocol is to establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD. In addition to providing a vehicle for enrollment of patients with chronic GVHD on NCI and NIH protocols, this study has several secondary objectives: a) To prospectively identify clinical and biological prognostic markers in patients with cGVHD; b) To develop clinically relevant cGVHD grading scales; c) To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation; d) To identify potential clinical and biological markers of cGVHD activity; e) To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects.
This is a non-therapeutic study emphasizing cross sectional and longitudinal data collection. The aim of data analysis is primarily hypothesis-generating. For study purposes, clinical data collection time points are scheduled every six months during the first three years of the study and then yearly. A total of 170 subjects will be enrolled onto this protocol and it is anticipated that this enrollment will take 4-5 years. The benefits from this protocol to the patients include undergoing a thorough multi-disciplinary evaluation and consultation by the cGVHD clinical team, including assessment and treatment recommendations. Patients enrolled in this natural history protocol will also be referred to experimental treatment protocols when appropriate. Risks are those of clinically indicated evaluations, as well as risks associated with research blood draws, imaging studies, and biopsies (defined and consented individually). Patient confidentiality will be protected and, with permission, information will be freely shared with the referring/treating physicians.
- Sponsoring Institute:
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National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Active Accrual Of New Subjects
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility Criteria:
INCLUSION CRITERIA:
Any patient age 1-75 referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independently of age or underlying diagnosis;
Patient or the patient's legal representative is able and willing to provide consent.
EXCLUSION CRITERIA:
Significant medical condition or any other significant circumstance that could in the PIs assessment affect the patient's ability to tolerate, comply, or complete the study;
Patients who in the PIs assessment have a life expectancy less than 3 months.
Because it is not always possible to make a clear clinical distinction between acute and chronic GVHD, patients with acute GVHD are not a-priori excluded until the possibility of chronic GVHD is reliably excluded on the basis of the clinical assessments in the cGVHD clinic.
- Special Instructions:
Currently Not Provided
- Keywords:
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Natural History
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Screening
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Biopsies
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Leukapheresis
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Questionnaires
- Recruitment Keywords:
-
None
- Conditions:
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Contacts:
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citations:
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Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33.
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Beschorner WE, Tutschka PJ, Santos GW. Chronic graft-versus-host disease in the rat radiation chimera. I. Clinical features, hematology, histology, and immunopathology in long-term chimeras. Transplantation. 1982 Apr;33(4):393-9. No abstract available.
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Tutschka PJ, Teasdall R, Beschorner WE, Santos GW. Chronic graft-versus-host disease in the rat radiation chimera. II. Immunological evaluation in long-term chimeras. Transplantation. 1982 Nov;34(5):289-94. No abstract available.
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Warren Grant Magnuson Clinical Center (CC) National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/19/2004
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