Chronic Graft Versus Host DiseaseNCT00637689
Improving Outcomes Assessment in Chronic GVHD
An observational study of Chronic Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 9 sites in United States.
Trial summary
The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- How many people
- 601 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2007to Feb 2028
- Phase
- Observational
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with chronic GVHD
Who may be able to join
- Age greater than or equal to 2 years
- Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
- Clinical or histologic diagnosis of chronic GVHD (overlap syndrome with acute GVHD is allowed
- Need for systemic treatment, defined as any medication or intervention delivered systemically, including extracorporeal photopheresis. If a patient only received topical or local therapy at diagnosis, but subsequently requires systemic treatment, they may be enrolled upon initiation of systemic therapy. (Note, these patients will be classified as incident or prevalent cases depending on time from chronic GVHD diagnosis, not start of systemic therapy)
- If a prevalent case (defined as enrollment three or more months after chronic GVHD diagnosis), then subject must be within 2 years of stem cell infusion
- If an incident case (enrollment less than 3 months after chronic GVHD diagnosis) then no limitation on time from transplantation
Show all 9Show fewer
- No evidence of primary disease relapseProgression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
- Evaluation at the transplant center at the time of study enrollment
- Signed, informed consent and if applicable, child assent
Who cannot join
- Inability to comply with study procedures
- Anticipated survival less than 6 months due to co-morbid disease
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
Memorial Sloan Kettering
New York, New York, 10065
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. We will accomplish our goals by studying a large number of people with chronic GVHD over several years using information collected from health care providers, patients, laboratory studies and diagnostic tests. Several transplant centers in the United States are collaborating on this project.
Read the detailed description
Chronic graft-versus-host disease (GVHD) is one of the most devastating long-term complications after infusion of allogeneic hematopoietic stem cells, and it remains one of the major barriers to successful transplantation. Relatively little progress has been made in understanding and improving treatments for chronic GVHD over the last 20 years, and the survival rate after diagnosis of chronic GVHD has barely improved despite advances in supportive care. The National Institutes of Health convened a Consensus Conference on this topic in June 2004 and recently published its recommendations on improving research methods in a series of six papers.
In our study, we will establish a multi-center, observational, longitudinal cohort in order to improve outcomes assessment in chronic GVHD with the specific aims of (1) validating prognostic factors for risk stratification; and (2) defining significant variables for a chronic GVHD activity index that predicts short-term (provider perception of change, patient perception of change, and changes in immunosuppressive medications) and longer-term outcomes (overall survival, time to discontinuation of systemic immunosuppressive therapy, and functional impairments). This goal will be accomplished by assembling a large modern cohort of people with chronic GVHD at four large core transplant centers. Approximately 700 people (half prevalent cases, half incident cases) with chronic GVHD will be enrolled. Every 3-6 months we will collect both objective and subjective measures reflecting disease activity, response to therapy, detailed physician assessments about organ involvement, and patient self-assessments about symptoms, functional status, and quality of life. Data will be used to test published hypotheses and the new recommendations emanating from the NIH Consensus conference. We will also be able to provide the detailed data needed to understand modern trends in chronic GVHD incidence, manifestations, and response to treatment. These studies are needed to operationalize the recommendations of the NIH Consensus conference, advance our understanding of chronic GVHD, and enhance our ability to conduct clinical trials.
- Conditions
- Chronic Graft Versus Host Disease
- Keywords
- Chronic graft versus host disease, Allogeneic hematopoietic cell transplantation, Biomarkers, Response criteria, Surrogate endpoints, Natural history
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Time to discontinuation of immunosuppression
Measured: 3 years
Functional impairments
Measured: 3 years
Secondary outcomes (3)
Provider perception of change
Measured: 6 months
Patient perception of change
Measured: 6 months
Changes in immunosuppressive medications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2017
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft Versus 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
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Stanford University, Dana-Farber Cancer Institute, Vanderbilt University, Medical College of Wisconsin, Washington University School of Medicine, H. Lee Moffitt Cancer Center and Research Institute, Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie J Lee, MD MPH, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637689
- Sponsor's protocol ID
- FHCRC-2192.00
- Other IDs
- U01CA118953-01A1, IR-6531, RG1000709
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2008
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
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 34126278Gandelman JS, Byrne MT, Mistry AM, Polikowsky HG, Diggins KE, Chen H, Lee SJ, Arora M, Cutler C, Flowers M, Pidala J, Irish JM, Jagasia MH. Machine learning reveals chronic graft-versus-host disease phenotypes and stratifies survival after stem cell transplant for hematologic malignancies. Haematologica. 2019 Jan;104(1):189-196. doi: 10.3324/haematol.2018.193441. Epub 2018 Sep 20.
PubMed 30237265Martin PJ, Storer BE, Inamoto Y, Flowers MED, Carpenter PA, Pidala J, Palmer J, Arora M, Jagasia M, Arai S, Cutler CS, Lee SJ. An endpoint associated with clinical benefit after initial treatment of chronic graft-versus-host disease. Blood. 2017 Jul 20;130(3):360-367. doi: 10.1182/blood-2017-03-775767. Epub 2017 May 11.
PubMed 28495794Palmer J, Chai X, Pidala J, Inamoto Y, Martin PJ, Storer B, Pusic I, Flowers ME, Arora M, Pavletic SZ, Lee SJ. Predictors of survival, nonrelapse mortality, and failure-free survival in patients treated for chronic graft-versus-host disease. Blood. 2016 Jan 7;127(1):160-6. doi: 10.1182/blood-2015-08-662874. Epub 2015 Nov 2.
PubMed 26527676Palmer J, Chai X, Martin PJ, Weisdorf D, Inamoto Y, Pidala J, Jagasia M, Pavletic S, Cutler C, Vogelsang G, Arai S, Flowers ME, Lee SJ. Failure-free survival in a prospective cohort of patients with chronic graft-versus-host disease. Haematologica. 2015 May;100(5):690-5. doi: 10.3324/haematol.2014.117283. Epub 2015 Feb 24.
PubMed 25715403Treister N, Chai X, Kurland B, Pavletic S, Weisdorf D, Pidala J, Palmer J, Martin P, Inamoto Y, Arora M, Flowers M, Jacobsohn D, Jagasia M, Arai S, Lee SJ, Cutler C. Measurement of oral chronic GVHD: results from the Chronic GVHD Consortium. Bone Marrow Transplant. 2013 Aug;48(8):1123-8. doi: 10.1038/bmt.2012.285. Epub 2013 Jan 28.
PubMed 23353804Arai S, Jagasia M, Storer B, Chai X, Pidala J, Cutler C, Arora M, Weisdorf DJ, Flowers ME, Martin PJ, Palmer J, Jacobsohn D, Pavletic SZ, Vogelsang GB, Lee SJ. Global and organ-specific chronic graft-versus-host disease severity according to the 2005 NIH Consensus Criteria. Blood. 2011 Oct 13;118(15):4242-9. doi: 10.1182/blood-2011-03-344390. Epub 2011 Jul 26.
PubMed 21791424