MULTIDISCIPLINARY CAR-T TEAM (submitted in 2019)

European Statement: 

  • Clinical Pharmacy Services

Author(s): 

MARGHERITA GALASSI
CHIARA DELLA COSTANZA
CLAUDIA TIRONE
SARA BERTOLI
ERNESTO RUFFINO
ELEONORA FERRARI
ELENA ALIPRANDI
VITO LADISA

What was done?: 

A multidisciplinary team (CAR-T team) was constituted for the management of CAR-T therapies (Chimeric Antigen Receptor T). The pharmacist was included in the team for the planning and organisational phase of the process.

Why was it done?: 

CAR-T cell therapies are a new advanced type of personalised immunotherapy against cancer. In the EU the authorised therapies are tisagenlecleucel and axicabtagene ciloleucel, both used in our centre as third line for the registered indication of diffuse large B-cell lymphoma. CAR-T therapies production and administration process consists of multiple stages: patient’s leukapheresis, genetic engineering of lymphocytes, lymphodepleting chemotherapy (LC), CAR-T cell infusion, monitoring of the patient. Considering the complexity of the procedure and the observance of specific schedules, these therapies should be administered in highly specialised centres complying with specific organisational requirements, with disposal of an adequate multidisciplinary team.

How was it done?: 

The pharmacist is responsible for the approval of the physician’s prescription, the LC preparation according to Good Manufacturing Practice (GMP), the LC distribution on scheduled time, the making available of treatments for supporting the patient until CAR-T infusion, and treatments after infusion for management of adverse events. At the arrival of the CAR-T product, the pharmacist is responsible for the check and release of it in good condition. The LC protocols foresee the administration of cyclophosphamide and fludarabine on the 5th, 4th and 3rd day before the CAR-T infusion, and are defined on the basis of the summary-of-product characteristics. The medications are provided locally and refunded by the national health system.

What has been achieved?: 

In our center 8 patients were treated with compassionate use of axicabtagene ciloleucel. The pharmacist’s presence in the multidisciplinary team was advantageous because, through validation of the therapies and verification of dosages, they guarantee further security to the patients. The high-tech automated centralisation and computerisation of chemotherapies at our centre ensured quality and safety of the preparations.

What next?: 

The realisation of defined paths and codified proceedings, the respect of fundamental timings for the success of the process and the chemotherapy preparation centralisation could lead to increased investment, decisive for obtaining a high quality product and process level. The experience, now limited to haematology, could be used for future CAR-T applications.

Keywords: 

  • Clinical pharmacyMultidisciplinary team
  • Patient safetyHigh risk medication
Conflict of interest: 
I have no potential conflict of interest to disclose

Pdf: