Feasibility Study of Collecting Multicenter Chronic GVHD Data

Completed

Conditions studied: Graft-Versus-Host Disease

In brief

Primary Objective: 1\. To determine the feasibility of conducting a multi-site longitudinal observational study of patients with chronic graft-versus-host disease (GVHD).

Key facts

Study ID

NCT00506233

Run by

M.D. Anderson Cancer Center

People needed

13

Starts

2006-08-01

Last updated by the study team

2012-07-31

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
• 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
• Diagnosis of chronic GVHD meeting the diagnostic criteria of the diagnosis and staging group of the NIH consensus conference
• 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)
• Progression-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, and agreement to be re-evaluated at the transplant center at 3 and 6 months
• Signed, informed consent and if applicable, child assent

You may not qualify if…

• Inability to verbally communicate in English
• Inability to comply with study procedures
• Anticipated survival less than 6 months due to co-morbid disease or persistent malignancy

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.