- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544032
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)
October 3, 2025 updated by: Incyte Corporation
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
Study Overview
Status
Available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Betty Hamilton, MD, The Cleveland Clinic
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 Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Actual)
October 8, 2025
Last Update Submitted That Met QC Criteria
October 3, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-34176-25-07
- INCA 34176-MA-GD-301
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.
Clinical Trials on Chronic Graft Vs. Host Disease
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Novartis PharmaceuticalsRecruitingChronic Graft vs. Host Disease | Graft vs. Host Disease | Corticosteroid-refractory Chronic Graft vs. Host DiseaseChina
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Dana-Farber Cancer InstituteBayer; Genzyme, a Sanofi CompanyCompleted
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Fundación Pública Andaluza para la gestión de la...CompletedChronic Graft vs Host DiseaseSpain
-
Shenzhen University General HospitalRecruitingGraft Vs Host DiseaseChina
-
National Cancer Institute (NCI)TerminatedGraft vs Host Disease | Graft-Versus-Host Disease | Chronic Graft vs. Host DiseaseUnited States
-
Dana-Farber Cancer InstituteCompletedGraft vs Host Disease | Chronic Graft vs Host Disease | cGVHDUnited States
-
National Cancer Institute (NCI)Completed
-
St. Petersburg State Pavlov Medical UniversityMinistry of Health, Russian FederationCompleted
-
Janssen Korea, Ltd., KoreaTerminatedChronic Graft vs Host DiseaseKorea, Republic of
-
Fundación Pública Andaluza para la gestión de la...RecruitingChronic Graft vs Host DiseaseSpain
Clinical Trials on axatilimab
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Syndax PharmaceuticalsDevPro BiopharmaActive, not recruitingIdiopathic Pulmonary FibrosisSpain, Taiwan, United Kingdom, Australia, France, Germany, Belgium, Italy, Canada, South Korea, Czechia, Poland, Romania
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Incyte Biosciences Japan GKActive, not recruiting
-
Incyte CorporationRecruitingChronic Graft-versus-host-diseaseChina
-
Incyte CorporationCompletedHealthy ParticipantsUnited States
-
Syndax PharmaceuticalsActive, not recruitingChronic Graft-versus-host-diseaseUnited States, Spain, Taiwan, France, Singapore, Belgium, Germany, Italy, Canada, Israel, Australia, United Kingdom, Greece, Poland, Portugal, South Korea
-
M.D. Anderson Cancer CenterIncyte, IncRecruitingChronic Myelomonocytic Leukemia (CMML) | Myelofibrosis (MF)United States
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Syndax PharmaceuticalsTerminatedCOVID | ARDS | Coronavirus | Cytokine Storm | Cytokine Release SyndromeUnited States
-
Stephen ShiaoMerck Sharp & Dohme LLC; Incyte CorporationRecruitingBreast Cancer | TNBC - Triple-Negative Breast CancerUnited States
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Stephen ShiaoMerck Sharp & Dohme LLC; Incyte CorporationNot yet recruitingBreast Cancer | TNBC - Triple-Negative Breast CancerUnited States
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University of MiamiIncyte CorporationRecruitingChronic Graft Versus Host Disease | cGVHDUnited States