A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Categories (click each to see list of all clinical trials associated with that category): BMT/GVHD (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Haddadin, Michael
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06388564?term=NCT06388564&rank=1#participation-criteria
Summary
Primary: 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.
Secondary: To determine the safety and tolerability of axatilimab in combination with ruxolitinib in participants with cGVHD.
To evaluate the clinical benefit of axatilimab in combination with ruxolitinib in participants with cGVHD with respect to secondary endpoints, assessed for each treatment group.
To assess the PK of axatilimab in combination with ruxolitinib in participants with cGVHD.
Exploratory: To assess OS in participants with cGVHD.
To assess NRM in participants with cGVHD.
To assess cumulative corticosteroid exposure in participants with cGVHD.
To compare changes in health-related quality of life in participants with cGVHD.
To assess the immunogenicity of axatilimab in combination with ruxolitinib in participants with cGVHD.
To evaluate the effect of axatilimab in combination with ruxolitinib on bone turnover markers in participants with cGVHD.
To assess the PD profile of axatilimab in combination with ruxolitinib in participants with cGVHD. To evaluate the effect of axatilimab in combination with ruxolitinib on blood biomarkers in participants with cGVHD.