What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

December 8, 2025Blood

Safety analysis of axatilimab in patients with chronic graft-versus-host disease in an expanded access program

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Safety analysis shows axatilimab treatment provides clinical benefit in patients with chronic graft-versus-host disease.

To analyze the safety of axatilimab in patients with chronic graft-versus-host disease enrolled in an expanded access program.
Open-label, multicenter expanded access program for patients with active cGVHD.
Enrolled patients received axatilimab 0.3 mg/kg every 2 weeks after failing ≥2 prior treatments.
Treatment-emergent adverse events were assessed from consent until 30 days post-treatment or transition to commercial product.
112 patients were enrolled, with 104 receiving axatilimab.
Among treated patients, 72.1% experienced treatment-emergent adverse events.
Most adverse events were manageable, with only 4.5% discontinuing due to toxicity or intolerance.

Stein et al. (2025) studied this question.

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December 8, 2025Blood

View Full Paper

Ask AI

Bookmark

Authors

Safety analysis shows axatilimab treatment provides clinical benefit in patients with chronic graft-versus-host disease.

To analyze the safety of axatilimab in patients with chronic graft-versus-host disease enrolled in an expanded access program.
Open-label, multicenter expanded access program for patients with active cGVHD.
Enrolled patients received axatilimab 0.3 mg/kg every 2 weeks after failing ≥2 prior treatments.
Treatment-emergent adverse events were assessed from consent until 30 days post-treatment or transition to commercial product.
112 patients were enrolled, with 104 receiving axatilimab.
Among treated patients, 72.1% experienced treatment-emergent adverse events.
Most adverse events were manageable, with only 4.5% discontinuing due to toxicity or intolerance.

Stein et al. (2025) studied this question.

View Full Paper

Ask AI

Bookmark