Phase IIb Study of Axatilimab Combined With Extracorporeal Photopheresis ECP for Treating Chronic Graft-versus-Host Disease

What this Trial Is About

Researchers are evaluating whether a combination of Axatilimab and Extracorporeal Photopheresis ECP is effective in treating chronic Graft-versus-Host Disease cGVHD, a complication that can occur after allogeneic hematopoietic cell transplantation. This Phase IIb study aims to assess the overall response rate and other health outcomes in participants with cGVHD who have previously undergone other therapies and may be steroid refractory or dependent. Participants will receive Axatilimab intravenously at 0.3 mgkg starting two weeks before ECP therapy, then bi-weekly during treatment cycles. ECP therapy will be given with varying frequencies twice weekly during the first three cycles, bi-weekly in cycles four to six, and specific sessions during cycle seven. After seven cycles, ECP may continue up to 12 months based on the investigators discretion. The total participation duration is approximately 15 months. During the study, participants will be monitored through treatment cycles with assessments including adverse events, corticosteroid use, duration of response, relapse-free survival, quality of life changes, and skin condition development. Researchers will primarily measure the best overall response rate up to 24 weeks. Safety and treatment effects will be followed for up to 15 months, involving clinical evaluations and symptom scoring to understand the therapys impact.

Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease