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Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease


N/A
1 Year
75 Years
Open (Enrolling)
Both
Graft vs Host Disease

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Trial Information

Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease


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.

Inclusion 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:

1. 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;

2. 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Steven Z Pavletic, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

040281

NCT ID:

NCT00092235

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Graft Vs Host Disease
  • Natural History
  • Screening
  • Biopsies
  • Leukapheresis
  • Questionnaires
  • Chronic Graft-Versus-Host Disease
  • cGVHD
  • Graft vs Host Disease

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892