A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * ≥ 12 years of age at the time of informed consent. * New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy. * History of 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells). * Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Received more than 1 prior allo-SCT. Prior autologous HCT is allowed. * Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD. * Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis. * Received systemic corticosteroids within 2 weeks prior to C1D1, regardless