Graft vs Host DiseaseNCT01902576
Chronic GVHD Response Measures Validation
An observational study of Graft vs Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 99 years
- Conditions the study is for
- Graft vs Host Disease
- How many people
- 383 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.
Who may be able to join
- 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
Who cannot join
- Inability to comply with study procedures
- Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
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.
- Conditions
- Graft vs Host Disease
- Medical subject headings
- Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion26 Sep 2019
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie J Lee, MD MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902576
- Sponsor's protocol ID
- 2710.00
- Other IDs
- RG1000980
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2013
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic GVHD Response Measures Validation
- ClinicalTrials.gov ID
- NCT01902576
- Acronym / sponsor ID
- 2710.00
- Conditions
- Graft vs Host Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to comply with study procedures
- Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 34126278Inamoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie J Lee, MD MPH principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft vs Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.