A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)

Incyte Corporation56 sites in 1 country1,500 target enrollmentAugust 1, 2023

ConditionscGVHD

Overview

Phase: N/A
Intervention: Not specified
Conditions: cGVHD
Sponsor: Incyte Corporation
Enrollment: 1500
Locations: 56
Primary Endpoint: Overall Burden of cGVHD diagnosis and severity
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

October 15, 2027

Last Updated

last month

Study Type

Observational

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•There are no exclusion criteria for this study

Outcomes

Primary Outcomes

Overall Burden of cGVHD diagnosis and severity

Time Frame: 36 months

Secondary Outcomes

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)