Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease

cGVHD Clinical Trial

— THRIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919511
• Other study ID #: MA-GVHD-401
• Status: Recruiting
• Start date: August 2, 2023
• Est. completion date: October 15, 2027

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 15, 2027
• Est. primary completion date: October 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• cGVHD
• Graft vs Host Disease

Intervention

Other:
• Non-Interventional
This is an observational study

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Massachusetts Cancer Research Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	City of Hope	Duarte	California
United States	The University of Kansas Clinical Research Center	Fairway	Kansas
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Burden of cGVHD diagnosis and severity		36 months
Secondary	To describe personal and healthcare resources associated with the management of cGVHD		36 months
Secondary	To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD		Up to 36 months