This protocol applies to patients with low/intermediate-risk acute promyelocytic leukemia who do not reach the required molecular endpoint at the end of ATRA/ATO-based consolidation and require a next-line approach.
A white blood cell count at or below 10,000/ml places this patient in the low/intermediate-risk APL category. Most clinicians today use this two-tier classification — high risk (>10,000/ml) versus low/intermediate risk — to guide therapy selection at each line.
The prior treatment — chemotherapy-free ATRA/ATO-based consolidation (following ATRA/ATO-based induction) — did not achieve PML-RARA negative status by PCR at the end of consolidation. Failure to reach this molecular target is the trigger for escalation to the current protocol.
Salvage strategies in this relapsed/refractory setting centre on arsenic trioxide-based combinations. Several agent combinations have shown activity in regaining molecular response; the specific options, their sequencing, and individualised considerations are detailed in the full structured protocol.