Trial Search Results

Chronic GVHD Response Measures Validation

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fred Hutchinson Cancer Research Center

Stanford Investigator(s):

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)

Ages Eligible for Study

7 Years - 99 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822
Not Recruiting