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Factors Determining Outcomes in Patients With Graft-Versus-Host Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified June 14, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00092235
First received: September 21, 2004
Last updated: June 20, 2017
Last verified: June 14, 2017
  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
Chronic Graft vs Host Disease

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To establish a multidisciplinary clinic infrastructure for study of pathogenesis and natural history of cGVHD [ Time Frame: Ongoing ]
  • To prospectively identify candidate markers for clinical and biological prognostic factors in patients with cGVHD and develop a prognostic model [ Time Frame: 2 years + 3 months after protocol entry ]
  • To develop clinically relevant cGVHD grading scales [ Time Frame: Ongoing ]
  • To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation [ Time Frame: Ongoing ]
  • To identify potential clinical and biological markers of cGVHD activity [ Time Frame: Ongoing ]
  • To improve our current understanding of the biology of cGVHD associated graft-versus-tumor effects (GVT). [ Time Frame: Ongoing ]

Estimated Enrollment: 550
Study Start Date: September 17, 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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Steven Z Pavletic, M.D. (240) 760-6174 sp326h@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Z Pavletic, M.D. National Cancer Institute (NCI)
  More Information

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

Responsible Party: National Cancer Institute (NCI)
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: June 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
cGVHD-associated graft-versus-tumor effects (GVT)
Allo-HSCT controls
Leukapheresis
Chronic Graft-Versus-Host Disease
cGVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017