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Chronic GVHD Response Measures Validation
Not Recruiting
Trial ID: NCT01902576
Purpose
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). Hopefully, this will also lead to being better able to predict which patients will
respond to what therapies.
Official Title
Chronic GVHD Response Measures Validation
Stanford Investigator(s)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Inability to comply with study procedures
- Complete resolution of chronic GVHD at the time of enrollment (patient must have some
measurable chronic GVHD activity)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822