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

February 16, 2024 updated by: Incyte Corporation

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts Cancer Research Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University Of North Carolina At Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Recruiting
        • The Ohio State University
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
At risk for GVHD
Equal or Greater than 18 years old post alloSCT
Other: Non-Interventional
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Burden of cGVHD diagnosis and severity
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe personal and healthcare resources associated with the management of cGVHD
Time Frame: 36 months
36 months
To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-GVHD-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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