NCT05919511

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

32 active sites

Status
recruiting

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 Progress66%
Aug 2023Oct 2027

First Submitted

Initial submission to the registry

May 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

May 5, 2023

Last Update Submit

March 20, 2026

Conditions

Keywords

chronic graft versus host diseasecGVHDMA-GVHD-401THRIVEGVHDchronic GVHDallogenic stem cell transplant (alloSCT)

Outcome Measures

Primary Outcomes (1)

  • Overall Burden of cGVHD diagnosis and severity

    36 months

Secondary Outcomes (2)

  • To describe personal and healthcare resources associated with the management of cGVHD

    36 months

  • To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD

    Up to 36 months

Study Arms (1)

At risk for GVHD

Equal or Greater than 18 years old post alloSCT

Other: Non-Interventional

Interventions

This is an observational study

At risk for GVHD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants greater than or equal to 18 years of age who have had Allogenic SCT 90 to 180 days prior to enrollment

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80309, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Moffit Cancer Center

Orlando, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Georgia Cancer Center

Augusta, Georgia, 30912, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Group

Chicago, Illinois, 60612, United States

RECRUITING

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

The University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

RECRUITING

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

COMPLETED

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts Cancer Research Center

Boston, Massachusetts, 02114, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08602, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43201, United States

RECRUITING

Oregon Health Sciences University

Portland, Oregon, 97239, United States

RECRUITING

Geisinger Health Systems

Danville, Pennsylvania, 17822, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood and saliva

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

Incyte Corporation Call Center (ex-US)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 26, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations