Peritransplant palifermin use and lymphocyte recovery after T-cell replete, matched related allogeneic hematopoietic cell transplantation.

A previously conducted randomized, double-blind, placebo-controlled study from 2000-2003 tested peri-transplant palifermin (KGF) in 100 recipients of T-replete matched related donor allogeneic hematopoietic transplant (MRD allo-HCT). The use of KGF in preclinical transplant models, including an autologous non-human primate model, has been associated with improved immune reconstitution. Therefore, we investigated whether palifermin treated patients (n = 69) had improved absolute lymphocyte counts (ALCs) at days 30, 60 and 100 after transplant compared to placebo treated patients (n = 31). No statistically significant difference in ALC was noted at these time points. Additionally, there was no difference in ALC between patients who received low (240μg/kg) vs. high (720μg/kg) dose palifermin. Patients with a day 30 ALC of >600 ×10/L had a trend towards improved progression-free survival (49% vs. 29%, p=0.07), lower transplant-related mortality (18% vs. 35%, p=0.1) and grade II-IV aGvHD (31% vs. 47%, p=0.14), but this was not influenced by palifermin therapy. We conclude that following myeloablation and a T-replete MSD allogeneic graft, peri-transplant palifermin does not accelerate early lymphocyte recovery. Studies combining palifermin with other agents (as in pre-clinical models) may be required to improve immune reconstitution after allo-HCT.