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Vol. 21 No. 6 (2023): Blood Transfusion 6-2023 (November-December)

Managing leukapheresis in adult and pediatric patients eligible for chimeric antigen receptor T-cell therapy: suggestions from an Italian Expert Panel

Authors

Key words: CAR T-cell therapy, cryopreservation, leukapheresis, timing

Abstract

Chimeric antigen receptor (CAR) T-cell therapy relies on T cells engineered to target specific tumor antigens such as CD-19 in B-cell malignancies. In this setting, the commercially available products have offered a potential
long-term cure for both pediatric and adult patients. Yet manufacturing CAR T cells is a cumbersome, multistep process, the success of which strictly depends on the characteristics of the starting material, i.e., lymphocyte collection yield and composition. These, in turn, might be affected by patient factors such as age, performance status, comorbidities, and previous therapies. Ideally, CAR T-cell therapies are a one-off treatment; therefore, optimization and the possible standardization of the leukapheresis procedure is critical, also in view of the novel CAR T cells currently under investigation for hematological malignancies and solid tumors. The most recent Best Practice recommendations for the management of children and adults undergoing CAR T-cell therapy provide a comprehensive guide to their use. However, their application in local practice is not straightforward and some grey areas remain. An Italian Expert Panel of apheresis specialists and hematologists from the centers authorized to administer CAR T-cell therapy took part in a detailed discussion on the following: 1) pre-apheresis patient evaluation; 2) management of the leukapheresis procedure, also in special situations represented by low lymphocyte count, peripheral blastosis, pediatric population <25 kg, and the COVID-19 outbreak; and 3) release and cryopreservation of the apheresis unit. This article presents some of the important challenges that must be faced to optimize the leukapheresis procedure and offers suggestions as to how to improve it, some of which are specific to the Italian setting.

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Authors

Giovanna Leone - Unit of Immuno-Hematology and Transfusion Medicine, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy

Valentina Baldini - Immunotransfusion Service, San Gerardo Hospital, Monza, Italy

Stefania Bramanti - Cancer Center, Humanitas Cancer Center, IRCCS, Rozzano, Milan, Italy

Roberto Crocchiolo - Transfusion Medicine Service, ASST Niguarda Hospital, Milan, Italy

Salvatore Gattillo - Immuno-Hematology and Transfusion Medicine Unit, San Raffaele Hospital, Milan, Italy

Stefano Ermini - Transfusion Service, University Hospital Meyer, Children’s Hospital, Florence, Italy

Valeria Giudice - Immuno-Hematology and Transfusion Medicine Unit, University Hospital Sant' Orsola-Malpighi, Bologna, Italy

Ivana Ferrero - Stem Cell Transplantation and Cellular Therapy Laboratory, Paediatric Onco-Hematology Division, Regina Margherita Children's Hospital, City of Health and Science of Turin, Turin, Italy

Tiziana Moscato - Stem Cell Transplant and Cellular Therapies Unit, Hemato-Oncology and Radiotherapy Department, Bianchi-Melacrino-Morelli Hospital, Reggio Calabria, Italy

Raffaella Milani - Immunohematology and Transfusion Medicine Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy

Maria Gozzer - Hematology, Department of Translational and Precision Medicine, Sapienza University Policlinico Umberto I, Rome, Italy

Nicola Piccirillo - Department of Diagnostic Imaging, Oncological Radiotherapy and Hematology, Complex Operational Unit of Blood Transfusion, Gemelli University Hospital IRCCS, Rome, Italy

Cristina Tassi - Stem Cell Transplantation and Cellular Therapy Laboratory, Paediatric Onco-Hematology Division, Regina Margherita Children's Hospital, City of Health and Science of Turin, Turin, Italy

Valter Tassi - Blood Bank and Immunohematology, City of Health and Science of Turin, Turin, Italy

Paola Coluccia - Immunohematology and Transfusion Medicine Service, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

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