A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 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.
You may not be if
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 of indication.
Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
History of acute or chronic pancreatitis.
History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
Active symptomatic myositis.
Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization.
Pregnant or breastfeeding.
Clareo Health | A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
