ClinicaliQ Trial Snapshot
- A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06585774.
- What is being tested: The efficacy and safety of axatilimab (a CD40 ligand antagonist) combined with corticosteroids versus placebo plus corticosteroids as first-line treatment for moderate to severe chronic graft-versus-host disease (cGVHD).
- Patient eligibility overview: Adults with newly diagnosed moderate or severe cGVHD following allogeneic hematopoietic stem cell transplantation who have not received prior systemic treatment for cGVHD.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Eligibility Snapshot
- : * ≥ 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 allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible. * Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry. * Willingness to avoid pregnancy or fathering children.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.