cGVHDTHRIVENCT05919511
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
An observational study of cGVHD, run by Incyte Corporation at 37 sites in United States.
Trial summary
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cGVHD
- What is being tested?
- Non-Interventional
- How many people
- 1,500 participants
- Where
- 37 sitesUnited States
- Study dates
- 1 Aug 2023to 15 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants greater than or equal to 18 years of age who have had Allogenic SCT 90 to 180 days prior to enrollment
Who may be able to join
- Age ≥ 18 years inclusive at the time of signing the ICF
- Allogeneic SCT 90 to 180 days prior to enrollment
- Able to comprehend and willing to provide informed consent
- Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
United States37 sites, 36 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Georgia Cancer Center
Augusta, Georgia, 30912
- Recruiting
University of Colorado
Aurora, Colorado, 80309
- Recruiting
Sarah Cannon Blood Cancer Center at St. Davids's South Austin Medical Center
Austin, Texas, 78704
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35294
- Recruiting
Massachusetts Cancer Research Center
Boston, Massachusetts, 02114
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Rush University Medical Group
Chicago, Illinois, 60612
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
- Recruiting
The Ohio State University
Columbus, Ohio, 43201
- Recruiting
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
- Recruiting
Geisinger Health Systems
Danville, Pennsylvania, 17822
- Recruiting
Colorado Blood Cancer Institute/Presbyterian St. Luke's
Denver, Colorado, 80218
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Tristar Centennial Blood & Marrow Transplant
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08602
- Completed
Tulane Cancer Center
New Orleans, Louisiana, 70112
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
- Recruiting
Moffit Cancer Center
Orlando, Florida, 33612
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
- Recruiting
Oregon Health Sciences University
Portland, Oregon, 97239
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
- Recruiting
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Methodist Hospital
San Antonio, Texas, 78229
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
- Conditions
- cGVHD
- Being tested
- Non-Interventional
- Keywords
- chronic graft versus host disease, cGVHD, MA-GVHD-401, THRIVE, GVHD, chronic GVHD, allogenic stem cell transplant (alloSCT)
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| At risk for GVHD | Equal or Greater than 18 years old post alloSCT Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Burden of cGVHD diagnosis and severity
Measured: 36 months
Secondary outcomes (2)
To describe personal and healthcare resources associated with the management of cGVHD
Measured: 36 months
To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Aug 2023
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919511
- Sponsor's protocol ID
- MA-GVHD-401
- Acronym
- THRIVE
- Status last verified
- Oct 2026
- First submitted
- 5 May 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
- ClinicalTrials.gov ID
- NCT05919511
- Acronym / sponsor ID
- THRIVE / MA-GVHD-401
- Conditions
- cGVHD
- Keywords
- chronic graft versus host disease, cGVHD, MA-GVHD-401, THRIVE, GVHD, chronic GVHD, allogenic stem cell transplant (alloSCT)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 26 Jun 2023 (actual)
- 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 prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At risk for GVHD | – | Other: Non-InterventionalEqual or Greater than 18 years old post alloSCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants greater than or equal to 18 years of age who have had Allogenic SCT 90 to 180 days prior to enrollment
Key inclusion criteria (4 listed)
- Age ≥ 18 years inclusive at the time of signing the ICF
- Allogeneic SCT 90 to 180 days prior to enrollment
- Able to comprehend and willing to provide informed consent
- Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalThis is an observational study | Other | At risk for GVHD |
Primary outcome
Overall Burden of cGVHD diagnosis and severity
Time frame: 36 months
2 secondary outcomes
To describe personal and healthcare resources associated with the management of cGVHD
Time frame: 36 months
To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD
Time frame: Up to 36 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 6 Oct 2026.
- Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease (THRIVE)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of cGVHD, run by Incyte Corporation at 37 sites 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites 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?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Burden of cGVHD diagnosis and severity (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.