ClinicaliQ Trial Snapshot
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT07124078.
- What is being tested: Axatilimab (a CSF1R inhibitor) is being evaluated against best available therapy in paediatric patients with chronic graft-versus-host disease (cGVHD) who have failed at least 2 prior systemic treatment lines.
- Patient eligibility overview: The trial includes children with steroid-refractory or steroid-dependent cGVHD following allogeneic haematopoietic stem cell transplantation, with documented inadequate response to multiple preceding therapies, representing a treatment-resistant population.
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 Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
Eligibility Snapshot
- : * Aged ≥ 2 to < 18 years at the time of signing the informed consent. * Active, moderate to severe cGVHD, requiring systemic immune suppression. * Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed. * Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, imatinib, methotrexate, or ibrutinib. * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.