RESUMEN
Nursing leaders at the University of South Alabama (USA) Health collaborated to explore the need for a structured practice model for advanced practice providers (APP). The goal of this collaboration was to create an organizational structure where APPs could thrive clinically and professionally.
Asunto(s)
Enfermería de Práctica Avanzada/organización & administración , Liderazgo , Modelos Organizacionales , Asistentes Médicos/organización & administración , Alabama , Prestación Integrada de Atención de Salud/normas , HumanosRESUMEN
BACKGROUND: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. Combotox is a 1:1 mixture of RFB4-dgA and HD37-dgA which are immunotoxins that target the CD22 and CD19 antigens, respectively. Combotox has different toxicities and targets than chemotherapy and is, thus, a new candidate for the treatment of patients with relapsed ALL. Preclinical data have demonstrated which Combotox is effective in killing pre-B-ALL cell lines and cells from patients with pre-B ALL. METHODS: We designed and conducted a Phase 1 dose-escalation study using Combotox in children with refractory or relapsed B-lineage-ALL. Seventeen patients aged 1 to 16 years were enrolled in this multi-institution study. They were treated at 4-dose levels: 2 mg/m2, 4 mg/m2, 5 mg/m2, and 6 mg/m2. RESULTS: The maximum tolerated dose was 5 mg/m2 and graft versus host disease defined the maximum tolerated dose. Three patients experienced complete remission. Six additional patients experienced a decrease of >95% in their peripheral blood blast counts, and 1 patient experienced a decrease of 75%. CONCLUSIONS: Combotox can be safely administered to children with refractory leukemia. It has clinically important anticancer activity as a single agent. The recommended dose for future studies is 5 mg/m2/dose.