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

Recruiting

• Conditions: cGVHD

• Registration Number: NCT05919511
• Lead Sponsor: Incyte Corporation

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-26
• Study Start: 2023-08-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2027-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Burden of cGVHD diagnosis and severity	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (32)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Moffit Cancer Center; 🇺🇸 Orlando, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

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