RecruitingChronic Graft-versus-host-disease

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Eligible age

12+ yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

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).

Sponsor: Incyte Corporation

You may qualify 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 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.

You may not qualify if…

✕ Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
✕ Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
✕ Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
✕ Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
✕ Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
✕ Prior treatment with CSF-1R targeted therapies.
✕ Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
✕ Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.