Factors Determining Outcomes in Patients With Graft-Versus-Host Disease - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00092235

Purpose

Background:

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.

Objectives:

To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD.
To prospectively identify clinical and biological prognostic markers in patients with cGVHD.
To develop clinically relevant cGVHD grading scales.
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation.
To identify potential clinical and biological markers of cGVHD activity.
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects.

Eligibility:

-Patients age 1-75 referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis.

Design:

Patient undergoes initial clinical and labotory multispecialty work-up at the NCI cGVHD clinic.
Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and/or rule-out other pathologic process (in adults only).
Long tem data collection for evaluation of long-term outcomes will be conducted every six months during the first three years of the study and then yearly.

Condition
Graft vs Host Disease

Study Type:	Observational
Official Title:	Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	520
Study Start Date:	September 2004

Detailed Description:

Background:

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.

Objectives:

To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD.
To prospectively identify clinical and biological prognostic markers in patients with cGVHD.
To develop clinically relevant cGVHD grading scales.
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation.
To identify potential clinical and biological markers of cGVHD activity.
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects.

Eligibility:

-Patients age 1-75 referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis.

Design:

Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic.
Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and/or rule-out other pathologic process (in adults only).
Long tem data collection for evaluation of long-term outcomes will be conducted every six months during the first three years of the study and then yearly.

Eligibility

Ages Eligible for Study:	1 Year to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:
1. 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;
2. 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.

Note: 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092235

Contacts

Contact: NCI Referral Office

1-888-NCI-1937

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003 Apr;9(4):215-33. Review.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martires KJ, Baird K, Steinberg SM, Grkovic L, Joe GO, Williams KM, Mitchell SA, Datiles M, Hakim FT, Pavletic SZ, Cowen EW. Sclerotic-type chronic GVHD of the skin: clinical risk factors, laboratory markers, and burden of disease. Blood. 2011 Oct 13;118(15):4250-7. Epub 2011 Jul 26.

Clark J, Yao L, Pavletic SZ, Krumlauf M, Mitchell S, Turner ML, Cowen EW. Magnetic resonance imaging in sclerotic-type chronic graft-vs-host disease. Arch Dermatol. 2009 Aug;145(8):918-22.

Imanguli MM, Swaim WD, League SC, Gress RE, Pavletic SZ, Hakim FT. Increased T-bet+ cytotoxic effectors and type I interferon-mediated processes in chronic graft-versus-host disease of the oral mucosa. Blood. 2009 Apr 9;113(15):3620-30. Epub 2009 Jan 23.

ClinicalTrials.gov Identifier:	NCT00092235 History of Changes
Obsolete Identifiers:	NCT00331968
Other Study ID Numbers:	040281, 04-C-0281
Study First Received:	September 21, 2004
Last Updated:	January 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Natural History
Screening
Biopsies
Leukapheresis

Questionnaires
Chronic Graft-Versus-Host Disease
cGVHD

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on February 07, 2012