Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose
HCPCS code
Name of the Procedure:
Axicabtagene ciloleucel (Yescarta) Technical Term: Autologous Anti-CD19 CAR T-Cell Therapy (HCPCS code Q2041)
Summary
Axicabtagene ciloleucel is a treatment involving the modification of a patient's own T-cells to fight certain types of blood cancers. This therapy includes collecting T-cells, modifying them in a lab to better target cancer cells, and then reinfusing them into the patient.
Purpose
Axicabtagene ciloleucel is designed to treat relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The treatment aims to improve survival rates and achieve cancer remission.
Indications
- Relapsed or refractory large B-cell lymphoma
- Diffuse large B-cell lymphoma (DLBCL) that has not responded to other treatments
- Patients who have undergone at least two prior systemic treatment regimens
Preparation
- Pre-treatment assessment includes blood tests, imaging tests, and a thorough medical evaluation.
- Patients may need to undergo leukapheresis (a procedure to collect T-cells from the blood).
- Patients may be required to stop certain medications and may need to fast before the procedure.
Procedure Description
- Leukapheresis: Blood is drawn from the patient, and T-cells are separated and collected.
- T-cell Engineering: T-cells are sent to a lab where they are modified to express a Chimeric Antigen Receptor (CAR) targeting CD19 protein on cancer cells.
- Cell Expansion: The engineered T-cells are multiplied to create enough cells for treatment.
- Chemotherapy Preparation: A short course of chemotherapy may be given to prepare the body.
- Cell Infusion: The modified T-cells are infused back into the patient through an IV.
- Tools: Leukapheresis machine, specialized lab equipment for genetic modification.
- Anesthesia: Usually not required, but sedation may be used during leukapheresis.
Duration
The leukapheresis process takes about 2-4 hours. The entire procedure from cell collection to infusion can take several weeks.
Setting
- Leukapheresis is performed in a hospital or specialized clinic.
- T-cell infusion is typically done in a hospital, often requiring inpatient monitoring.
Personnel
- Hematologists/Oncologists
- Nurses
- Transfusion Medicine Specialists
- Lab Technicians
Risks and Complications
- Cytokine release syndrome (CRS)
- Neurological toxicities
- Infection
- Anemia and other blood-related issues
- Management involves close monitoring and medications to counteract severe reactions.
Benefits
- Potential for cancer remission
- Improved survival rates for patients with refractory lymphoma
- Benefits may start to appear within weeks of infusion.
Recovery
- Close monitoring in a hospital for at least a week post-infusion.
- Outpatient follow-up to monitor for delayed side effects.
- Recovery time varies; patients might experience fatigue, infection risk, and need ongoing support.
Alternatives
- Additional rounds of chemotherapy
- Radiation therapy
- Bone marrow or stem cell transplant
- Immunotherapy
- Each alternative has varying success rates and risks; choice depends on individual patient factors.
Patient Experience
- Leukapheresis might cause mild discomfort or fatigue.
- During infusion, some may experience fever, chills, or other mild symptoms.
- Post-procedure, patients often need support to manage fatigue, potential side effects, and emotional stress.