GVHD
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
Incyte Study ID:
MA-GVHD-401
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
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)
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Aug 2023 - Oct 2027
TYPE
Observational
PHASE
N/A
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
University of North Carolina at Chapel Hill
Chapel Hill, NC, US, 27514
Status
Recruiting
Location
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, TX, US, 75246
Status
Recruiting
Location
Tulane Cancer Center
New Orleans, LA, US, 70112
Status
Completed
Location
The Ohio State University
Columbus, OH, US, 43201
Status
Recruiting
Location
Levine Cancer Institute
Charlotte, NC, US, 28204
Status
Recruiting
Location
City of Hope
Duarte, CA, US, 91010
Status
Recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Age ≥ 18 years inclusive at the time of signing the ICF
- Allogeneic SCT 90 to 180 days prior to enrollment
Exclusion Criteria
- There are no exclusion criteria for this study
Protocol Summary
Incyte Study ID:
MA-GVHD-401
Primary Purpose:
N/A
Allocation:
N/A
Study Design:
N/A
Masking:
N/A
Interventions:
Other
Enrollment:
1500
Primary Outcome
Open
Overall Burden of cGVHD diagnosis and severity
Timeframe: 36 months
Secondary Outcome
Open
To describe personal and healthcare resources associated with the management of cGVHD
Timeframe: 36 months
To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD
Timeframe: Up to 36 months