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Trial record 1 of 1 for:    NCT01902576
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Chronic GVHD Response Measures Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902576
Recruitment Status : Active, not recruiting
First Posted : July 18, 2013
Last Update Posted : September 25, 2020
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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). Hopefully, this will also lead to being better able to predict which patients will respond to what therapies.

Condition or disease
Graft vs Host Disease

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Study Type : Observational
Actual Enrollment : 383 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic GVHD Response Measures Validation
Actual Study Start Date : June 2013
Actual Primary Completion Date : September 26, 2019
Estimated Study Completion Date : February 2025

Primary Outcome Measures :
  1. Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response. [ Time Frame: 18 months ]
    This measure is intended to capture impairments caused by chronic GVHD. We expect that change in the CGVHD-AI could be used to measure treatment response because it will correlate with clinically significant changes reported by physicians and patients. The CGVHD-AI would be most appropriate for use in clinical trials where the goal is symptom relief and decreased disease activity.

Secondary Outcome Measures :
  1. To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival. [ Time Frame: 18 months ]
    This measure is intended for use as an intermediate endpoint that predicts subsequent failure-free survival, defined as absence of death, relapse and requirement for new therapy, i.e., events that constitute treatment failures in clinical trials. The CGVHD-FFS would be most appropriate for phase II and III trials testing agents intended to change the underlying biology of the syndrome, for example by inducing immunologic tolerance.

Biospecimen Retention:   Samples With DNA
Whole blood samples (30mL) processed for peripheral blood mononuclear cells (PBMC), plasma, and granulocytes.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902576

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
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Principal Investigator: Stephanie J Lee, MD MPH Fred Hutchinson Cancer Research Center
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Responsible Party: Fred Hutchinson Cancer Research Center Identifier: NCT01902576    
Other Study ID Numbers: 2710.00
RG1000980 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases