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
Incyte Corporation
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
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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. Exclu…
Interventions
- DrugAxatilimab
Axatilimab will be administered at protocol defined dose.
- DrugRuxolitinib
Ruxolitinib will be administered at protocol defined dose.
- DrugCorticosteroids
Corticosteroids will be administered at protocol defined dose.
Locations (70)
- Mayo Clinic HospitalPhoenix, Arizona
- City of Hope Medical CenterDuarte, California
- University of California-Los Angeles Medl Cntr-Oncology Center Bowyer ClinicLos Angeles, California
- Stanford Cancer CenterStanford, California
- University of Colorado Cancer CenterAurora, Colorado
- Colorado Blood Cancer InstituteDenver, Colorado