This trial is active, not recruiting.

Condition chronic graft versus host disease
Sponsor Fred Hutchinson Cancer Research Center
Collaborator University of Minnesota - Clinical and Translational Science Institute
Start date September 2007
End date May 2014
Trial size 601 participants
Trial identifier NCT00637689, FHCRC-2192.00, IR-6531, U01CA118953-01A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Overall survival
time frame: 3 years
Time to discontinuation of immunosuppression
time frame: 3 years
Functional impairments
time frame: 3 years

Secondary Outcomes

Provider perception of change
time frame: 6 months
Patient perception of change
time frame: 6 months
Changes in immunosuppressive medications
time frame: 6 months

Eligibility Criteria

Male or female participants at least 2 years old.

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

Additional Information

Official title Improving Outcomes Assessment in Chronic GVHD
Principal investigator Stephanie J Lee, MD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.