T-cell acute lymphoblastic leukaemia (T-ALL)

Active Ingredient: Nelarabine

Indication for Nelarabine

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

Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

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

650 mg/m² once a day

Route of admnistration

Intravenous

Defined daily dose

650 - 650 mg per m² of body surface area (BSA)

Dosage regimen

From 650 To 650 mg per m² of body surface area (BSA) once every day for 5 day(s)

Detailed description

The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m² administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days.

In clinical studies, the 650 mg/m² and 1,500 mg/m² dose have both been used in patients in the age range 16 to 21 years. Efficacy and safety were similar for both regimens. The prescribing physician should consider which regimen is appropriate when treating patients in this age range.

Limited clinical pharmacology data are available for patients below the age of 4 years.

Dose modification

Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater. Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.

Dosage considerations

It should be administered intravenously as a one-hour infusion.

Active ingredient

Nelarabine

Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis. This results in cell death. Other mechanisms may contribute to the cytotoxic effects of nelarabine. In vitro, T-cells are more sensitive than B-cells to the cytotoxic effects of nelarabine.

Read more about Nelarabine

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