Status:
ACTIVE_NOT_RECRUITING
Chronic GVHD Response Measures Validation
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
7-99 years
Brief Summary
The purpose of this study is to develop and validate endpoint measures that can accurately determine whether patients are responding to treatment for chronic Graft-versus-Host Disease (GVHD). Hopefull...
Eligibility Criteria
Inclusion
- Age 7 years or older
- Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis.
- Diagnosis of chronic GVHD according to the criteria of the diagnosis and scoring group of the NIH consensus conference (Patient must have at least one diagnostic manifestation of chronic GVHD or one distinctive manifestation with pathological confirmation of the diagnosis. Concurrent acute GVHD manifestations will be allowed as long as at least one classic chronic manifestation is present.)
- Initiation of a new systemic treatment for chronic GVHD in the past 4 weeks or anticipated within the next 4 weeks. Systemic treatment is defined as any medication or intervention that has intended systemic effects, including extracorporeal photopheresis, regardless of prior lines of therapy or prior treatment with the agent(s). If a patient is restarting a treatment to which they were previously exposed, they must have been off of it for at least 4 weeks before restarting.
- No evidence of persistent or progressive malignancy at the time of enrollment
- Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center up to four subsequent times: at 3 months, 6 months, and 18 months after enrollment and once if another treatment is added for chronic GVHD.
- Signed, informed consent
Exclusion
- Inability to comply with study procedures
- Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01902576
Start Date
June 1 2013
End Date
February 1 2027
Last Update
September 17 2025
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109