Improving Outcomes Assessment in Chronic GVHD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Stanford University
Dana-Farber Cancer Institute
Vanderbilt University
Medical College of Wisconsin
Washington University School of Medicine
H. Lee Moffitt Cancer Center and Research Institute
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Lee, Stephanie, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00637689
First received: March 12, 2008
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. We will accomplish our goals by studying a large number of people with chronic GVHD over several years using information collected from health care providers, patients, laboratory studies and diagnostic tests. Several transplant centers in the United States are collaborating on this project.


Condition
Chronic Graft Versus Host Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Outcomes Assessment in Chronic GVHD

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to discontinuation of immunosuppression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Functional impairments [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Provider perception of change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient perception of change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in immunosuppressive medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Some centers are collecting serum, plasma, cells and urine.


Enrollment: 601
Study Start Date: September 2007
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Chronic graft-versus-host disease (GVHD) is one of the most devastating long-term complications after infusion of allogeneic hematopoietic stem cells, and it remains one of the major barriers to successful transplantation. Relatively little progress has been made in understanding and improving treatments for chronic GVHD over the last 20 years, and the survival rate after diagnosis of chronic GVHD has barely improved despite advances in supportive care. The National Institutes of Health convened a Consensus Conference on this topic in June 2004 and recently published its recommendations on improving research methods in a series of six papers.

In our study, we will establish a multi-center, observational, longitudinal cohort in order to improve outcomes assessment in chronic GVHD with the specific aims of (1) validating prognostic factors for risk stratification; and (2) defining significant variables for a chronic GVHD activity index that predicts short-term (provider perception of change, patient perception of change, and changes in immunosuppressive medications) and longer-term outcomes (overall survival, time to discontinuation of systemic immunosuppressive therapy, and functional impairments). This goal will be accomplished by assembling a large modern cohort of people with chronic GVHD at four large core transplant centers. Approximately 700 people (half prevalent cases, half incident cases) with chronic GVHD will be enrolled. Every 3-6 months we will collect both objective and subjective measures reflecting disease activity, response to therapy, detailed physician assessments about organ involvement, and patient self-assessments about symptoms, functional status, and quality of life. Data will be used to test published hypotheses and the new recommendations emanating from the NIH Consensus conference. We will also be able to provide the detailed data needed to understand modern trends in chronic GVHD incidence, manifestations, and response to treatment. These studies are needed to operationalize the recommendations of the NIH Consensus conference, advance our understanding of chronic GVHD, and enhance our ability to conduct clinical trials.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with chronic GVHD

Criteria

Inclusion Criteria:

  • Age greater than or equal to 2 years
  • Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
  • Clinical or histologic diagnosis of chronic GVHD (overlap syndrome with acute GVHD is allowed
  • Need for systemic treatment, defined as any medication or intervention delivered systemically, including extracorporeal photopheresis. If a patient only received topical or local therapy at diagnosis, but subsequently requires systemic treatment, they may be enrolled upon initiation of systemic therapy. (Note, these patients will be classified as incident or prevalent cases depending on time from chronic GVHD diagnosis, not start of systemic therapy)
  • If a prevalent case (defined as enrollment three or more months after chronic GVHD diagnosis), then subject must be within 2 years of stem cell infusion
  • If an incident case (enrollment less than 3 months after chronic GVHD diagnosis) then no limitation on time from transplantation
  • No evidence of primary disease relapseProgression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
  • Evaluation at the transplant center at the time of study enrollment
  • Signed, informed consent and if applicable, child assent

Exclusion Criteria:

  • Inability to comply with study procedures
  • Anticipated survival less than 6 months due to co-morbid disease
  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: NCT00637689

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
University of Minnesota - Clinical and Translational Science Institute
Stanford University
Dana-Farber Cancer Institute
Vanderbilt University
Medical College of Wisconsin
Washington University School of Medicine
H. Lee Moffitt Cancer Center and Research Institute
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Stephanie J Lee, MD MPH Fred Hutchinson Cancer Research Center
  More Information

No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee, Stephanie, Full Member, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00637689     History of Changes
Other Study ID Numbers: FHCRC-2192.00, U01 CA 118953-01A1,, IR-6531
Study First Received: March 12, 2008
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Chronic graft versus host disease
Allogeneic hematopoietic cell transplantation
Biomarkers
Response criteria
Surrogate endpoints
Natural history

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

ClinicalTrials.gov processed this record on October 29, 2014