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

ConditioncGVHD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

There are no exclusion criteria for this study

Trial population

Participants greater than or equal to 18 years of age who have had Allogenic SCT 90 to 180 days prior to enrollment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional

    Other intervention

    This is an observational study

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: At risk for GVHD1 intervention

Trial outcomes

Primary outcomes

1

Overall Burden of cGVHD diagnosis and severity

Time frame
36 months

Secondary outcomes

1

To describe personal and healthcare resources associated with the management of cGVHD

Time frame
36 months
2

To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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