Improving Outcomes Assessment in Chronic GVHD
4 other identifiers
observational
601
1 country
9
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedApril 20, 2026
April 1, 2026
9.7 years
March 12, 2008
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall survival
3 years
Time to discontinuation of immunosuppression
3 years
Functional impairments
3 years
Secondary Outcomes (3)
Provider perception of change
6 months
Patient perception of change
6 months
Changes in immunosuppressive medications
6 months
Eligibility Criteria
People with chronic GVHD
You may qualify if:
- 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
- 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
You may not qualify if:
- Inability to comply with study procedures
- Anticipated survival less than 6 months due to co-morbid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- University of Minnesotacollaborator
- Stanford Universitycollaborator
- Dana-Farber Cancer Institutecollaborator
- Vanderbilt Universitycollaborator
- Medical College of Wisconsincollaborator
- Washington University School of Medicinecollaborator
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (9)
Stanford University
Stanford, California, 94305, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (7)
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.
PMID: 34126278DERIVEDGandelman 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.
PMID: 30237265DERIVEDMartin 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.
PMID: 28495794DERIVEDPalmer 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.
PMID: 26527676DERIVEDPalmer 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.
PMID: 25715403DERIVEDTreister 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.
PMID: 23353804DERIVEDArai 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.
PMID: 21791424DERIVED
Biospecimen
Some centers are collecting serum, plasma, cells and urine.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie J Lee, MD MPH
Fred Hutchinson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 18, 2008
Study Start
September 1, 2007
Primary Completion
May 1, 2017
Study Completion (Estimated)
February 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04