Administering chimeric antigen receptor (CAR)-T cell therapy is a complex process that must be performed properly to ensure that the very expensive single-dose, potentially curative treatment is as effective and safe as possible.
To ensure that commercial CAR-T cell products are administered appropriately and that patients are thoroughly monitored, the Food and Drug Administration (FDA) requires that care teams adhere to specific guidelines. Staff members at Baylor University Medical Center (BUMC), in Dallas, Texas, have created a detailed checklist to make sure that these guidelines are followed, and they conduct a comprehensive audit after CAR-T therapy is administered to identify any problems that may have occurred during the process.
Christina Barrow, BSN, RN, BMTCN, a professional development educator at BUMC, documented that process and shared her findings at the ONS 44th Annual Congress in Anaheim, California, April 13. Her most important finding was that two overlooked aspects of CAR-T cell-associated care were due to staff failing to refer to a detailed checklist of tasks.
CAR-T is a novel type of immunotherapy that uses genetically engineered T cells to target cancer cells for destruction by a patient’s immune system.
BUMC has been approved since January 2018 to administer axicabtagene ciloleucel (Yescarta), which is approved to treat young adults with B cell precursor acute lymphoblastic leukemia and adults with relapsed large B cell lymphoma. Seven patients have received treatment with the product at BUMC, and audits of their charts were conducted to assess compliance with required program components, Barrow said.
The medical center recently received approval to administer another commercial CAR-T product, tisagenlecleucel (Kymriah), to patients with B cell precursor acute lymphoblastic leukemia, but has yet to administer the treatment, Barrow added.
The audits of CAR-T administration at BUMC, Barrow said, identified opportunities for improvement in two areas: nursing documentation of patient education, and inpatient availability of Actemra (tociluzimab)—given if immune cells attack patients’ healthy organs, causing cytokine release syndrome. According to the checklist, two doses of tociluzimab must be on hand before a patient’s treatment with CAR-T therapy begins.
Both these aspects of care are included on the institution’s CAR-T infusion checklist, and Barrow concluded that making sure to refer to the list before each treatment step will prevent employees from overlooking these areas in the future.
The checklist for drug administration and patient monitoring was designed to ensure administration of all the components of a Risk Evaluation and Mitigation Strategy program required by the FDA; it’s designed to manage side effects and ensure that the benefits of these treatments outweigh the risks. The checklist also prompts compliance with product inserts and BUMC program standards. Among other elements, the list reminds nurses to provide patient education, meet prerequisites for drug administration, give each patient a wallet card outlining potential side effects of axicabtagene ciloleucel that is to be shown to all treating doctors, and set aside two doses of tociluzimab. Also detailed on the list are steps on thawing and infusing the cellular product, checking a patient’s vital signs, giving premedications, and administering the product.
Because CAR-T is a new technology, staff members from the institution’s Blood and Marrow Transplant (BMT) program developed the checklist based on practices from its stem cell infusion processes, Barrow said. Baylor staff have been trained to use the checklist, which is available in a CAR-T resource binder for bedside staff.
Quarterly audits of patient charts identified a few barriers to meeting these requirements, Barrow reported: The products are made by different manufacturers, all CAR-T products are different because they include the cells of individual patients, and there’s no standard industry process for administering these drugs.
To improve compliance, BUMC has created a core group of CAR-T champions identified by the unit’s nursing manager. They have re-educated staff on facets of CAR-T administration including use of the checklist, and they act as a resource on the unit about administration issues. In addition, components of the process are being built into the cancer center’s new electronic health record.
Administration is ongoing as part of BMT program standards and REMS requirements, Barrow said.
Barrow, C. Developing a checklist to ensure staff compliance to chimeric antigen receptor (CAR) T cell infusion requirements. Presented at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, California. Abstract 5415.