MRD +ve B-cell precursor ALL 1 cycle for induction followed by up to 3 additional cycles for consolidation. Single induction or consolidation cycle: 28 days of continuous IV infusion followed by 14 days treatment-free interval (total of 42 days).
Patient weighing ≥45 kg Induction cycle 1 & consolidation cycles 2-4 (fixed-dose): 28 mcg daily on days 1-28; 14-day treatment-free interval on days 29-42.
Patient weighing <45 kg Induction cycle 1 & consolidation cycles 2-4 (BSA-based dose): 15 mcg/m
2 daily (Max: 28 mcg daily) on days 1-28; 14-day treatment-free interval on days 29-42. Premed:
Adult Prednisone 100 mg IV or equiv (eg, dexamethasone 16 mg) 1 hr prior to 1st dose in each cycle.
Ped Dexamethasone 5 mg/m
2 (Max dose: 20 mg) prior to 1st dose in 1st cycle & when restarting infusion after ≥4 hr interruption in 1st cycle.
Relapsed or refractory B-cell precursor ALL 2 induction cycles followed by 3 additional cycles for consolidation & up to 4 additional cycles of continued therapy. Single induction or consolidation cycle: 28 days continuous IV infusion followed by 14 days treatment-free interval (total of 42 days). Single cycle of continued therapy: 28 days of continuous IV infusion followed by 56 days treatment-free interval (total of 84 days).
Patient weighing ≥45 kg Induction cycle 1 (fixed-dose): 9 mcg daily on days 1-7; 28 mcg daily on days 8-28; 14-day treatment-free interval on days 29-42. Induction cycle 2 & consolidation cycles 3-5 (fixed dose): 28 mcg daily on days 1-28; 14-day treatment-free interval on days 29-42. Continued therapy cycles 6-9 (fixed dose): 28 mcg daily on days 1-28; 56-day treatment free interval on days 29-84.
Patient weighing <45 kg Induction cycle 1 (BSA-based dose): 5 mcg/m
2 daily (Max: 9 mcg daily) on days 1-7; 15 mcg/m
2 daily (Max: 28 mcg daily) on days 8-28; 14-day treatment-free interval on days 29-42. Induction cycle 2 & consolidation cycles 3-5 (BSA-based dose): 15 mcg/m
2 daily (Max: 28 mcg daily) on days 1-28; 14-day treatment-free interval on days 29-42. Continued therapy cycles 6-9 (BSA-based dose): 15 mcg/m
2 daily (Max: 28 mcg daily) on days 1-28; 56-day treatment-free interval on days 29-84. Premed:
Adult Dexamethasone 20 mg 1 hr prior to 1st dose of each cycle, prior to a step dose (eg, cycle 1 day 8) & when restarting an infusion after an interruption of ≥4 hr.
Ped Dexamethasone 5 mg/m
2 (Max dose: 20 mg) prior to 1st dose in the 1st cycle, prior to step dose (eg, cycle 1 day 8), & when restarting an infusion after an interruption of ≥4 hr in the 1st cycle.