Single cycle treatment: Continuous IV infusion for 28 days followed by 14-day treatment-free interval.
MRD +ve B-cell precursor ALL Patient ≥45 kg Cycle 1 (fixed-dose): 28 mcg daily on days 1-28. Consolidation cycles 2-4: 28 mcg daily on days 1-28.
Premed Adult Prednisolone 100 mg IV or equiv 1 hr prior to 1st dose in each cycle.
Relapse or refractory B-cell precursor ALL Patient ≥45 kg Cycle 1 (fixed-dose): Initially 9 mcg daily on days 1-7 then 28 mcg daily on days 8-28. Cycle 2: 28 mcg daily for days 1-28. Consolidation cycles 3-5: 28 mcg daily on days 1-28. Continued therapy cycles 6-9: 28 mcg daily for days 1-28 followed by 56-day treatment-free interval.
Patient <45 kg Cycle 1 (BSA-based dose): Initially 5 mcg/m
2 daily (not to exceed 9 mcg daily) on days 1-7 then 15 mcg/m
2 daily (not to exceed 28 mcg daily) on days 8-28. Cycle 2: 15 mcg/m
2 daily (not to exceed 28 mcg daily) for days 1-28. Consolidation cycles 3-5: 15 mcg/m
2 daily (not to exceed 28 mcg daily) on days 1-28. Continued therapy cycles 6-9: 28 mcg daily for days 1-28 followed by 56-day treatment-free interval.
Premed Adult Dexamethasone 20 mg 1 hr prior to 1st dose of each cycle prior to step dose (eg, cycle 1 day 8) & when restarting after ≥4 hr interruption.
Ped Dexamethasone 5 mg/m
2 up to max: 20 mg prior to 1st dose in 1st cycle prior to step dose (eg, cycle 1 day 8) & when restarting after ≥4 hr interruption in 1st cycle.