Chronic GVHD Response Measures Validation



Status:Recruiting
Conditions:Orthopedic, Hematology
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:7 - 99
Updated:10/3/2018
Start Date:June 2013
End Date:February 2020
Contact:Chareeni Kurukulasuriya
Email:ckurukul@fredhutch.org
Phone:(206) 667-6830

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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.


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)
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Stephanie J Lee, MD MPH
Phone: 206-667-6830
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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