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1.
Bull Cancer ; 108(12S): S98-S103, 2021 Dec.
Article in French | MEDLINE | ID: mdl-34802718

ABSTRACT

CAR-T cells are an innovative treatment for an increasing number of patients, particularly since the extension of their indication to mantle lymphoma and multiple myeloma. Several complications of CAR T-cell therapy, that were first described as exceptional, have now been reported in series of patients, since its first clinical use in 2011. Among them, cardiac complications, delayed cytopenias, acute and chronic Graft versus Host Disease, and tumoral lysis syndrome are recognized as specific potent complications following CAR T-cells infusion. During the twelfth edition of practice harmonization workshops of the Francophone society of bone marrow transplantation and cellular therapy (SFGM-TC), a working group focused its work on the management of these complications with focuses the epidemiology, the physiopathology and the risk factors of these 4 side effects. Our recommendations apply to commercial CAR-T cells, in order to guide strategies for the management of complications associated with this new therapeutic approach.


Subject(s)
Graft vs Host Disease/etiology , Heart Diseases/etiology , Immunotherapy, Adoptive/adverse effects , Neutropenia/etiology , Tumor Lysis Syndrome/etiology , Graft vs Host Disease/epidemiology , Humans , Incidence , Neutropenia/therapy , Receptors, Chimeric Antigen , Risk Factors , T-Lymphocytes/transplantation
2.
Bull Cancer ; 108(12S): S65-S71, 2021 Dec.
Article in French | MEDLINE | ID: mdl-33678408

ABSTRACT

Chimeric antigen receptor (CAR) T cells are a new class of anti-cancer therapy that involves manipulating autologous or allogeneic T cells to express a CAR directed against a membrane antigen. In Europe, tisagenlecleucel (Kymriah™) has marketing authorization for the treatment of relapsed / refractory acute lymphoblastic leukemia (ALL) in children and young adults, in addition to the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL); the marketing authorization for axicabtagene ciloleucel (Yescarta™) is for the treatment of relapsed / refractory high-grade B-cell lymphoma and for the treatment of primary mediastinal B-cell lymphoma. Both cell products are genetically modified autologous T cells directed against CD19. These recommendations, drawn up by a working group of the Francophone Society of Bone Marrow transplantation and cellular Therapy (SFGM-TC) relate to the management of patients and the supply chain: medium-term complications, in particular cytopenias and B-cell aplasia, nursing and psychological supportive care. In another work, we will address long-term monitoring, post-marketing authorization pharmacovigilance and issues relating to JACIE and regulatory authorities. These recommendations are not prescriptive; their aim is to provide guidelines for the use of this new therapeutic approach. The purpose of this workshop is to outline the organizational aspects of this new therapeutic approach.


Subject(s)
Biological Products/therapeutic use , Immunotherapy, Adoptive/methods , Receptors, Antigen, T-Cell/therapeutic use , Receptors, Chimeric Antigen , T-Lymphocytes/transplantation , Antibiotic Prophylaxis , Antigens, CD19/immunology , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/therapeutic use , Biological Products/adverse effects , Follow-Up Studies , Graft vs Host Disease/immunology , Humans , Immunotherapy, Adoptive/adverse effects , Infections , Lymphoma, Large B-Cell, Diffuse/therapy , Lymphopenia/immunology , Neutropenia/immunology , Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy , Societies, Medical , Time Factors
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