Background: Blinatumomab is a bispecific murine monoclonal antibody that selectively directs the human immune system against cancer cells, thereby encouraging the patient’s own healthy lymphocytes to attack the leukaemia cells. In recent years, Blinatumomab has been used to treat B-cell Acute Lymphoblastic Leukaemia (ALL), including in pediatric patients, and AIFA (Italian Medicines Agency) has recently issued new guidelines for the administration of the drug. Consequently, at the Pediatric Oncohaematology Centre of the ‘G. Salesi’ Pediatric Hospital in Ancona, there arose a need for an Operating Instruction to support nursing care for pediatric patients undergoing Blinatumomab infusion. Objective: The primary objective is to provide an Operating Instruction regarding the administration of Blinatumomab. The secondary objective is to enable healthcare professionals to explain and guide the child/adolescent and their parents through the treatment pathway in the Pediatric Oncohaematology Department and its continuation at home. Materials and methods: A literature review was conducted to describe ALL and standard therapeutic treatments, using both printed sources and online databases such as PubMed and Google Scholar. Information made available by the AIL, the AIRC and the EMA was also consulted. For the drafting and implementation of the Operating Instruction, however, two product information sheets were examined: one for Blinatumomab, made available by AIFA on 11 February 2025, and one for Tocilizumab, made available by AIFA on 12 June 2025. The lists of Active Therapeutic Protocol Registers made available by AIFA, updated to 9 March 2026, were consulted. In addition, Revision No. 2 of 28 January 2021 of the Care Addendum – Use of Blinatumomab and Bortezumib – AIEOP-BFM ALL 2017 was analysed. The Operating Instructon is divided into: Purpose and scope, Target audience, Management and nursing care, Tocilizumab, Home immunotherapy, Recommendations for the child and parents, Distribution and storage of the document. Results and Discussion: The work carried out led to the implementation of the Operating Instruction in March 2026, which is currently in use in the Pediatric Haematology-Oncology Department of the “G. Salesi” Hospital in Ancona. The O.I. contains the new therapeutic guidelines approved by AIFA and the method of administration of Blinatumomab. It outlines the role of the nurse in monitoring and managing complications that may arise during its administration. It specifies the supportive therapies to be provided before, during and after the start of the monoclonal antibody infusion. Furthermore, home immunotherapy is presented as an option to allow the patient to continue treatment in their own home. Discussions with medical and nursing staff highlighted the importance of sharing the O.I. with the entire team. The aim is to standardise care and ensure that healthcare professionals and patients carefully follow the recommendations and precautions, thereby ensuring the safe and effective use of Blinatumomab. Conclusions: The Operating Instruction ‘Nursing management of patients receiving Blinatumomab infusion’ has been shared and adopted by the entire team at the Pediatric Oncology and Haematology Centre of the ‘G. Salesi’ Pediatric Hospital in Ancona. The use of Blinatumomab represents a new therapeutic approach and a significant advance in the treatment of Acute Lymphoblastic Leukaemia, particularly in pediatric patients. Keywords: ALL, pediatric patient, Blinatumomab, Operating Instruction.
Background: Il farmaco Blinatumomab è un anticorpo monoclonale di tipo murino, bispecifico, che dirige il sistema immunitario umano selettivamente contro le cellule tumorali, favorendo l’aggressione delle cellule leucemiche da parte dei linfociti sani del paziente stesso. Negli ultimi anni il Blinatumomab è impiegato per il trattamento della Leucemia Linfoblastica Acuta (LLA) di tipo B anche in ambito pediatrico e recentemente l’AIFA (Agenzia Italiana del Farmaco) ha fornito nuove indicazioni alla somministrazione del farmaco. Pertanto presso il Centro di Oncoematologia Pediatrica dell’Ospedale Pediatrico “G. Salesi” di Ancona è nata l’esigenza di avere un’Istruzione Operativa a supporto dell’assistenza infermieristica al paziente pediatrico sottoposto a infusione di Blinatumomab. Obiettivo: L’obiettivo primario è fornire un’Istruzione Operativa riguardo la somministrazione del Blinatumomab. L’obiettivo secondario è quello di mettere gli operatori nelle condizioni di spiegare e guidare il bambino/adolescente e i genitori nel percorso terapeutico in SOsD Oncoematologia Pediatrica e nel suo proseguimento al proprio domicilio. Materiali e metodi: È stata revisionata la letteratura per descrivere la LLA e i trattamenti terapeutici tradizionali, utilizzando sia fonti cartacee, sia banche dati online quali PubMed e Google Scholar. Inoltre sono state consultate le informazioni rese disponibili dall’AIL, dall’AIRC e dall’EMA. Per la stesura e l’implementazione dell’Istruzione Operativa, invece, sono state esaminate le due schede tecniche: del Blinatumomab, resa disponibile dall’AIFA il 11/02/2025, e del Tocilizumab, resa disponibile dall’AIFA il 12/06/2025. Sono stati consultati gli elenchi dei Registri dei Protocolli Terapeutici Attivi messi a disposizione dall’AIFA, aggiornati al 09/03/2026. Inoltre è stata analizzata la revisione n° 2 del 28/01/2021 dell'Addendum assistenziale - Uso del Blinatumomab e Bortezumib – AIEOP-BFM ALL 2017. L'istruzione operativa si divide in: Scopo e campo di applicazione, Destinatari, Gestione e assistenza infermieristica, Tocilizumab, Immunoterapia domiciliare, Raccomandazioni per il bambino e i genitori, Distribuzione e conservazione del documento. Risultati e Discussione: Il lavoro svolto ha portato all’implementazione dell’Istruzione Operativa nel Marzo 2026, attualmente in uso presso l’Oncoematologia Pediatrica dell’Ospedale “G. Salesi” di Ancona. L’I.O. contiene le nuove indicazioni terapeutiche approvate dall’AIFA e la modalità di somministrazione del Blinatumomab. È delineato il comportamento dell’infermiere nel monitoraggio e nella gestione delle complicanze che possono insorgere durante la sua somministrazione. Sono indicate le terapie di supporto da fornire prima, durante e dopo l'avvio dell’infusione dell'anticorpo monoclonale. Inoltre viene presentata l’immunoterapia domiciliare come opzione per consentire al paziente di proseguire la terapia nel proprio domicilio. Dal confronto con il personale medico-infermieristico è emersa l’importanza di condividere l’I.O. con tutta l’equipe. Il fine è quello di uniformare l’assistenza e garantire che operatori sanitari e pazienti seguano attentamente le raccomandazioni e le precauzioni, assicurando un uso sicuro ed efficace del Blinatumomab. Conclusioni: L’Istruzione Operativa "Gestione infermieristica del paziente con infusione di Blinatumomab” è condivisa e adottata da tutto il team del Centro di Onco-Ematologia Pediatrica dell’Ospedale Pediatrico “G. Salesi” di Ancona. L'utilizzo del Blinatumomab rappresenta un nuovo approccio terapeutico e un progresso significativo per il trattamento della Leucemia Linfoblastica Acuta soprattutto nei pazienti pediatrici. Parole chiave: LLA, paziente pediatrico, Blinatumomab, Istruzione Operativa.
LA LEUCEMIA LINFOBLASTICA ACUTA NEL BAMBINO: IMPLEMENTAZIONE DI UN’ISTRUZIONE OPERATIVA SULLA GESTIONE INFERMIERISTICA DEL PAZIENTE CON INFUSIONE DI BLINATUMOMAB IN ONCOEMATOLOGIA PEDIATRICA
GIOVANNINI, VALENTINA
2024/2025
Abstract
Background: Blinatumomab is a bispecific murine monoclonal antibody that selectively directs the human immune system against cancer cells, thereby encouraging the patient’s own healthy lymphocytes to attack the leukaemia cells. In recent years, Blinatumomab has been used to treat B-cell Acute Lymphoblastic Leukaemia (ALL), including in pediatric patients, and AIFA (Italian Medicines Agency) has recently issued new guidelines for the administration of the drug. Consequently, at the Pediatric Oncohaematology Centre of the ‘G. Salesi’ Pediatric Hospital in Ancona, there arose a need for an Operating Instruction to support nursing care for pediatric patients undergoing Blinatumomab infusion. Objective: The primary objective is to provide an Operating Instruction regarding the administration of Blinatumomab. The secondary objective is to enable healthcare professionals to explain and guide the child/adolescent and their parents through the treatment pathway in the Pediatric Oncohaematology Department and its continuation at home. Materials and methods: A literature review was conducted to describe ALL and standard therapeutic treatments, using both printed sources and online databases such as PubMed and Google Scholar. Information made available by the AIL, the AIRC and the EMA was also consulted. For the drafting and implementation of the Operating Instruction, however, two product information sheets were examined: one for Blinatumomab, made available by AIFA on 11 February 2025, and one for Tocilizumab, made available by AIFA on 12 June 2025. The lists of Active Therapeutic Protocol Registers made available by AIFA, updated to 9 March 2026, were consulted. In addition, Revision No. 2 of 28 January 2021 of the Care Addendum – Use of Blinatumomab and Bortezumib – AIEOP-BFM ALL 2017 was analysed. The Operating Instructon is divided into: Purpose and scope, Target audience, Management and nursing care, Tocilizumab, Home immunotherapy, Recommendations for the child and parents, Distribution and storage of the document. Results and Discussion: The work carried out led to the implementation of the Operating Instruction in March 2026, which is currently in use in the Pediatric Haematology-Oncology Department of the “G. Salesi” Hospital in Ancona. The O.I. contains the new therapeutic guidelines approved by AIFA and the method of administration of Blinatumomab. It outlines the role of the nurse in monitoring and managing complications that may arise during its administration. It specifies the supportive therapies to be provided before, during and after the start of the monoclonal antibody infusion. Furthermore, home immunotherapy is presented as an option to allow the patient to continue treatment in their own home. Discussions with medical and nursing staff highlighted the importance of sharing the O.I. with the entire team. The aim is to standardise care and ensure that healthcare professionals and patients carefully follow the recommendations and precautions, thereby ensuring the safe and effective use of Blinatumomab. Conclusions: The Operating Instruction ‘Nursing management of patients receiving Blinatumomab infusion’ has been shared and adopted by the entire team at the Pediatric Oncology and Haematology Centre of the ‘G. Salesi’ Pediatric Hospital in Ancona. The use of Blinatumomab represents a new therapeutic approach and a significant advance in the treatment of Acute Lymphoblastic Leukaemia, particularly in pediatric patients. Keywords: ALL, pediatric patient, Blinatumomab, Operating Instruction.| File | Dimensione | Formato | |
|---|---|---|---|
|
TESI GIOVANNINI VALENTINA.pdf
embargo fino al 24/10/2027
Dimensione
5.16 MB
Formato
Adobe PDF
|
5.16 MB | Adobe PDF |
I documenti in UNITESI sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
https://hdl.handle.net/20.500.12075/26465