A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Axatilimab: Axatilimab will be administered at protocol defined dose.
Ruxolitinib: Ruxolitinib will be administered at protocol defined dose.
Corticosteroids: Corticosteroids will be administered at protocol defined dose.
Study summary
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
Eligibility
Primary outcome measure(s)
- Objective Response Rate — 6 months
Defined as Complete Response (CR) or Partial Response (PR) at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | |
| City of Hope Medical Center | Duarte | California | |
| University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic | Los Angeles | California | |
| Stanford Cancer Center | Stanford | California | |
| University of Colorado Cancer Center | Aurora | Colorado | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Smilow Cancer Center-Yale | New Haven | Connecticut | |
| Mayo Clinic Jacksonville | Jacksonville | Florida | |
| Northwestern University | Chicago | Illinois | |
| The University of Chicago Medicine | Chicago | Illinois | |
| University of Maryland-Greenebaum Cancer Center | Baltimore | Maryland | |
| Washington University | St Louis | Missouri | |
| Fred and Pamela Buffett Cancer Center | Omaha | Nebraska | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Weill Cornell Medicine | New York | New York | |
| Mount Sinai Hospital | New York | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| The Ohio State University | Columbus | Ohio | |
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Md Anderson Cancer Center | Houston | Texas | |
| Fred Hutchinson Cancer Center | Seattle | Washington | |
| University of Washington | Seattle | Washington | |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan | Bruges | Belgium | |
| Universitair Ziekenhuis Antwerpen (Uza) | Edegem | Belgium | |
| Jessa Ziekenhuis | Hasselt | Belgium | |
| Universitair Ziekenhuis (Uz) Leuven | Leuven | Belgium | |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | Belgium | |
| Centre Hospitalier Universitaire (Chu) de Liege | Liège | Belgium | |
| AZ DELTA | Roeselare | Belgium | |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | |
| Princess Margaret Cancer Centre - University Health Network | Toronto | Ontario | |
| Chu Sainte-Justine | Montreal | Quebec | |
| Vancouver General Hospital | Vancouver | Canada | |
| Klinikum Der Johann Wolfgang Goethe University | Frankfurt am Main | Germany | |
| Universitatklinikum Freiburg | Freiburg I. Breisgau | Germany | |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | Germany | |
| Universitaetsklinikum Jena | Jena | Germany |
+ 28 more sites — see the full list on the official registry below.
On this site
📄 Jakafi (ruxolitinib) drug profile →More Incyte Corporation trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06388564 on ClinicalTrials.gov ↗ ← All trials in the UK