Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤21 years old at initial diagnosis.
For this indication, competent medicine agencies globally authorize below treatments:
52 - 52 mg per m² of body surface area (BSA)
From 52 To 52 mg per m² of body surface area (BSA) once every day for 5 day(s)
The recommended dose in monotherapy is 52 mg/m² of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days. Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥0.75 × 109/l) and return to baseline organ function. A 25% dose reduction may be warranted in patients experiencing significant toxicities. There is currently limited experience of patients receiving more than 3 treatment cycles.
The majority of patients who respond to clofarabine achieve a response after 1 or 2 treatment cycles. Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician.
An infusion time of >2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine.
There are no data on the pharmacokinetics, safety or efficacy of clofarabine in infants. Therefore, a safe and effective dosage recommendation for patients <1 year old has yet to be established.
Intravenous infusion over 2 hours.
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