Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Miami
About this trial
The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).
Eligibility criteria
Qualifiers
Recipient of allogeneic hematopoietic cell transplantation (HCT).
Age greater or equal to 12.
Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such as ruxolitinib, belumosudil, or ibrutinib. GVHD prophylaxis does not count as a prior line of therapy.
i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week
Disqualifiers
Pregnancy or breast-feeding.
Active relapse of underlying malignancy.
History or the presence of interstitial pneumonitis or drug-related pneumonitis.
Active gastrointestinal (GI) bleeding.
Trial design
Treatments tested in this trial
- Axatilimab
- Extracorporeal Photopheresis
Treatment groups
49 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Miami
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov