High-Dose Palifermin Shows Promise in Preventing Acute GVHD Following Unrelated Donor HCT

In this phase 1/2 trial of 31 patients undergoing reduced-intensity conditioning with HLA-matched unrelated donor peripheral-blood hematopoietic cell transplantation (HCT), palifermin was administered in escalating doses (180-720 μg/kg) on day -7. The recommended phase 2 dose of 720 μg/kg was well tolerated and notably resulted in no grade II-IV acute graft-versus-host disease (GVHD) among treated patients, although rates of severe chronic GVHD remained similar to historical controls. Lymphocyte phenotyping suggests that high-dose palifermin may modulate regulatory T cells (Treg) and naïve CD4+ T-cell counts.

These findings indicate that while high-dose palifermin is safe and can effectively prevent acute GVHD, its impact on chronic GVHD is limited, meriting further evaluation in larger studies.