Category: Federal Forum Posters
Purpose: The biologic medication filgrastim is approved by the Food and Drug Administration (FDA) to mobilize autologous hematopoietic stem cells for collection by leukapheresis for HSCT. The FDA-approved biosimilar tbo-filgrastim is currently used off-label for this indication in both autologous and allogeneic HSCT at the Tennessee Valley Healthcare System (TVHS). The purpose of this study is to compare the efficacy of filgrastim and the biosimilar product tbo-filgrastim for these indications.
Methods: This study will be approved by the Institutional Review Board prior to data collection. Patients for study inclusion will be identified from the bone marrow transplant clinic at TVHS. Patients will be included in data collection if they received either filgrastim or tbo-filgrastim for stem cell mobilization between September 1, 2012 and September 1, 2018. The primary objective is to compare the efficacy of tbo-filgrastim in mobilizing hematopoietic stem cells for autologous stem cell transplantation to the biotherapeutic reference product filgrastim. Additionally, secondary objectives will evaluate the use of filgrastim and tbo-filgrastim in allogeneic HSCT in addition to the use of plerixafor in both patient populations. For the purpose of this study, efficacy will be defined as donors eligible for leukapheresis on day 4 of filgrastim or tbo-filgrastim administration for stem cell mobilization. Data collected will include patient demographics, G-CSF dose and administration days, number of leukapheresis procedures, plerixafor use, and pre-specified laboratory parameters. Data will be extracted from the Veterans Integrated Service Network (VISN 9) data warehouse and directly accessed from patient chart review. All patient data will be de-identified and placed in password-protected documents on a restricted internal drive of the Veterans Health Administration (VHA) system.
Results: not applicable
Conclusion: not applicable
Anna Jackson
– PGY1 Pharmacy Resident, Tennessee Valley Healthcare System, Nashville, TN155 Views