New European guidelines on management of adults and children receiving CAR-T therapy will support healthcare professionals to deliver consistent and high quality care in ‘this rapidly moving field’, the authors conclude.
The ‘practical and clinically relevant’ recommendations cover patient eligibility and treatment protocols as well as more ‘challenging’ topics such as COVID-19 and vaccination.
Noting that three CAR-T products are currently licensed in Europe but with others already approved by US regulators, the best practice recommendations point out that the treatment comes with a risk of life-threatening toxicity and requires comprehensive training of staff including those in the intensive care unit.
Real-world evidence is still being collected on the benefits of these treatments as relates to usual standard of care, the guidelines state.
The recommendations for best practice put together by the European Society for Blood and Marrow Transplantation (EBMT)-Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association, outline the eligibility criteria, screening and tests that must be done before treatment begins.
It includes checklists on preparing patients for treatment in a CAR-T accredited centre, including possible complications to rule out before the infusion.
Potential complications include infection, cytokine-release syndrome and cardiovascular toxicity in the first month after treatment as well as lower vaccine responses including to COVID-19 in the medium term, the guidelines note.
Multidisciplinary teams doing longer-term follow up should be aware that prolonged cytopenias, hypogammaglobulinemia and infections are common and CAR-T centres should liaise with referral hospitals to ensure shared care arrangements are in place.
Speaking with the limbic, guideline co-author Dr Claire Roddie, consultant haematologist at University College London Hospitals NHS Foundation Trust said: ‘The CAR-T field is moving rapidly, as is understanding of clinical practice and management of toxicity.
‘Further, there are several newly available CAR-T therapeutics, licensed in the US and soon to be licensed by EMA.
‘Our recommendations represent a comprehensive, up-to-date guide for practicing haematologists/oncologists, covering all aspects of CAR-T care, from patient selection to long term follow-up, with contributions from an expert consortium of oncologists, neurologists, cardio-oncologists, cell therapy nurses and CAR-T pharmacists.’
She added the guideline committed had reviewed all the recent literature, including guidance on new CAR-T indications, ‘to make recommendations on challenging areas such as vaccination, COVID-19, and cardiac complications of CAR-T’.