Improving Outcomes Assessment in Chronic GVHD

Chronic Graft Versus Host Disease Clinical Trial

Official title:

Improving Outcomes Assessment in Chronic GVHD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00637689
• Other study ID #: FHCRC-2192.00
• Secondary ID: U01CA118953-01A1
• Status: Active, not recruiting
• Start date: September 2007
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 601
• Est. completion date: February 2026
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Memorial Sloan Kettering	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (10)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), Stanford University, University of Minnesota, Vanderbilt University, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years
Primary	Time to discontinuation of immunosuppression		3 years
Primary	Functional impairments		3 years
Secondary	Provider perception of change		6 months
Secondary	Patient perception of change		6 months
Secondary	Changes in immunosuppressive medications		6 months