B-cell acute lymphoblastic leukaemia

Active Ingredient: Tisagenlecleucel

Indication for Tisagenlecleucel

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)

Therapeutic intent: Curative procedure

Tisagenlecleucel is indicated for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

For this indication, competent medicine agencies globally authorize below treatments:

For patients 50 kg and below 0.2-5 x 10⁶ CAR-positive viable T cells/kg body weight and for patients >50 kg 0.1-2.5 x 10⁸ CAR-positive viable T cells

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 50 kg, intravenous, between 200,000 cells tisagenlecleucel per kilogram of body weight and 5,000,000 cells tisagenlecleucel per kilogram of body weight, one dose.

Regimen B: In case that patient weight is < 50 kg, intravenous, between 10,000,000 cells tisagenlecleucel and 250,000,000 cells tisagenlecleucel, one dose.

Detailed description

Tisagenlecleucel is intended for autologous use only.

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one or more infusion bags.

Dose in paediatric and young adult B-cell ALL patients:

The concentration of CARpositive viable T cells is dependent on indication and patient body weight.

For patients 50 kg and below: The dose is within a range of 0.2 to 5 × 10⁶ CAR-positive viable T cells per kg body weight.
For patients above 50 kg: The dose is within a range of 0.1 to 2.5 × 10⁸ CAR-positive viable T cells (non-weight based).

Pre-treatment conditioning (lymphodepleting chemotherapy)

The availability of tisagenlecleucel must be confirmed prior to starting the lymphodepleting regimen. Tisagenlecleucel is recommended to be infused 2 to 14 days after completion of the lymphodepleting chemotherapy.

Lymphodepleting chemotherapy may be omitted if a patient is experiencing significant cytopenia, e.g., white blood cell (WBC) count ≤1 000 cells/μL within one week prior to infusion.

If there is a delay of more than 4 weeks between completing lymphodepleting chemotherapy and the infusion and the WBC count is >1 000 cells/μL, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving tisagenlecleucel.

The recommended lymphodepleting chemotherapy regimen is:

Fludarabine (30 mg/m² intravenous daily for 4 days) and cyclophosphamide (500 mg/m² intravenous daily for 2 days starting with the first dose of fludarabine).

If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used:

Cytarabine (500 mg/m² intravenous daily for 2 days) and etoposide (150 mg/m² intravenous daily for 3 days starting with the first dose of cytarabine).

Pre-medication

To minimise potential acute infusion reactions, it is recommended that patients be premedicated with paracetamol and diphenhydramine or another H1 antihistamine within approximately 30 to 60 minutes prior to tisagenlecleucel infusion. Corticosteroids should not be used at any time except in the case of a lifethreatening emergency.

Clinical assessment prior to infusion

Tisagenlecleucel treatment should be delayed in some patient groups at risk.

Monitoring after infusion

Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of cytokine release syndrome and/or neurological events.
After the first 10 days following the infusion, the patient should be monitored at the physician’s discretion.
Patients should be instructed to remain within proximity (within 2 hours of travel) of a qualified clinical facility for at least 4 weeks following infusion.

Active ingredient

Tisagenlecleucel
Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells. Read more about Tisagenlecleucel

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