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How it is administered
Tisagenlecleucel is given as a one-time intravenous (IV) infusion. The medication is made from your own blood cells, which are collected through a procedure called leukapheresis. After the cells are modified in a lab, they are returned to you as a frozen suspension in one to three infusion bags. The product is thawed and infused directly into your vein over a short period, usually 10 to 20 minutes per bag.
Before receiving tisagenlecleucel, you may receive chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the treatment. You will also be given medications like acetaminophen and an antihistamine to help prevent infusion reactions.
How it works
Tisagenlecleucel is a type of CAR-T cell therapy. It works by using your own immune system to fight cancer. First, your T cells (a type of white blood cell) are collected from your blood. These cells are then genetically modified in a laboratory to recognize and attack cells that have a protein called CD19 on their surface, which is found on many B-cell cancers, including B-cell acute lymphoblastic leukemia (ALL).
Once the modified T cells are infused back into your body, they seek out and destroy cancer cells that express CD19. The therapy can also affect normal B cells, leading to a period of low B cell counts (B-cell aplasia). This targeted approach helps your immune system eliminate cancer cells that may not have responded to other treatments.
Common side effects
- Cytokine release syndrome (CRS): fever, low blood pressure, difficulty breathing, chills, severe nausea, vomiting, diarrhea, muscle or joint pain
- Infections (bacterial, viral, fungal)
- Hypogammaglobulinemia (low antibody levels)
- Fever
- Decreased appetite
- Headache
- Febrile neutropenia (fever with low white blood cell count)
- Bleeding
- Musculoskeletal pain
- Vomiting
- Encephalopathy (confusion, altered mental status)
- Diarrhea
- Hypotension (low blood pressure)
- Cough
- Nausea
- Pain
- Hypoxia (low oxygen)
- Tachycardia (fast heart rate)
- Edema (swelling)
- Fatigue
- Acute kidney injury
Other possible side effects include prolonged low blood counts (cytopenias), neurological toxicities (such as seizures, confusion, or difficulty speaking), and secondary cancers.
Who Should take it
Tisagenlecleucel is indicated for patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory (not responding to treatment) or has relapsed (come back) after at least two previous treatments. It is also used in adults with certain types of relapsed or refractory large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy.
This therapy is generally considered when other standard treatments have not worked or the disease has returned. It is not used as a first-line treatment and is not indicated for patients with primary central nervous system lymphoma.
Who should not take it
There are no absolute contraindications listed for tisagenlecleucel, but it should not be given to patients with active, uncontrolled infections, unresolved serious adverse reactions from previous chemotherapy (such as pulmonary or cardiac toxicity), active graft versus host disease, or worsening leukemia after lymphodepleting chemotherapy.
It is not recommended for use in pregnant women due to unknown risks to the fetus. Patients with active hepatitis B, hepatitis C, or HIV infection should not receive tisagenlecleucel, as there is no experience with manufacturing the product in these populations. Safety and effectiveness have not been established in patients over 65 years old for ALL.
Commonly used with
Tisagenlecleucel is typically used after other treatments for ALL have failed, such as chemotherapy and sometimes stem cell transplantation. Before receiving tisagenlecleucel, patients usually receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide to prepare the body for the CAR-T cells.
During or after treatment, supportive medications such as acetaminophen, antihistamines, tocilizumab (for cytokine release syndrome), and corticosteroids may be used to manage side effects.
Commonly tested with
Tisagenlecleucel has been studied in combination with lymphodepleting chemotherapy regimens, primarily fludarabine and cyclophosphamide. In clinical trials, supportive treatments like tocilizumab and corticosteroids were used to manage cytokine release syndrome and neurological side effects.
Other agents, such as antibiotics, antifungals, and immunoglobulin replacement, may be used as supportive care during and after tisagenlecleucel therapy.