Status:
ACTIVE_NOT_RECRUITING
Improving Outcomes Assessment in Chronic GVHD
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
University of Minnesota
Stanford University
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
2+ years
Brief 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 u...
Detailed 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 succe...
Eligibility Criteria
Inclusion
- 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
- Inability to comply with study procedures
- Anticipated survival less than 6 months due to co-morbid disease
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00637689
Start Date
September 1 2007
End Date
February 1 2027
Last Update
October 6 2025
Active Locations (9)
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1
Stanford University
Stanford, California, United States, 94305
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455