Purpose: A phase I/II study of PIXY321 following high-dose therapy (HDT) and autologous bone marrow transplantation (ABMT) was conducted to evaluate the safety and clinical potential of this agent. Patients and Methods: Fifty patients with Hodgkin's disease or non-Hodgkin's lymphoma (NHL) undergoing HDT and ABMT received PIXY321 post-ABMT in doses that ranged from 50 to 1,000 μg/m2/d either as intravenous (IV) or subcutaneous (SC) dosing until engraftment was reached. Results: If all doses are considered together, the median time to reach an absolute neutrophil count (ANC) ≥ 500/μL was 18 days and the median time to platelet transfusion independence was 21 days. At the estimated optimum dose of 750 μg/m2/d by SC injection once daily, the median time to reach an ANC ≥ 500/μL was 15 days and the median time to platelet transfusion independence was 16 days. Historical control patients who received granulocyte-macrophage colony-stimulating factor (GM-CSF) had a median time to an ANC ≥ 500/μL of 19 days and a median time to platelet independence of 26 days. Conclusion: The administration of PIXY321 post-ABMT was generally well tolerated and resulted in prompt engraftment in the majority of patients who underwent HDT and ABMT for lymphoid malignancies. The optimum dose and route of administration of PIXY321 suggested by this trial was 750 μg/m2/d by once-daily SC injection. Compared with historical control patients who received 2-hour IV GM-CSF, patients who received PIXY321 at 750 μg/m2/d by SC injection once daily had an improvement in the median days to neutrophil and platelet engraftment by 4 and 10 days, respectively.
ASJC Scopus subject areas
- Cancer Research