Improving Outcomes Assessment in Chronic GVHD

Running, not enrolling

Conditions studied: Chronic Graft Versus Host Disease

In brief

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.

Key facts

Study ID

NCT00637689

Run by

Fred Hutchinson Cancer Center

People needed

601

Starts

2007-09-01

Expected to finish

2027-02-01

Last updated by the study team

2026-04-20

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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