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Active, not recruitingNCT01902576Updated Sep 17, 2026

Chronic GVHD Response Measures Validation

An observational study in Graft vs Host Disease, sponsored by Fred Hutchinson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 7 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Fred Hutchinson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
383
Ages
7 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

  • Graft vs Host Disease

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In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 383 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 99 Years
Sexes eligible
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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
383 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response.

    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.

    Time frame: 18 months

Secondary outcomes

  1. To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival.

    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.

    Time frame: 18 months

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Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
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References and documents

Publications

  • Inamoto Y, Martin PJ, Onstad LE, Cheng GS, Williams KM, Pusic I, Ho VT, Arora M, Pidala J, Flowers MED, Gooley TA, Lawler RL, Hansen JA, Lee SJ. Relevance of Plasma Matrix Metalloproteinase-9 for Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Cell Transplantation. Transplant Cell Ther. 2021 Sep;27(9):759.e1-759.e8. doi: 10.1016/j.jtct.2021.06.006. Epub 2021 Jun 12. PubMed 34126278 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01902576
Lead sponsor
Fred Hutchinson Cancer Center
Responsible party
Sponsor
First posted
Jul 18, 2013
Start date
Jun 2013
Primary completion
Sep 26, 2019
Completion
Feb 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Stephanie J Lee, MD MPH
principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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