This protocol addresses patients with relapsed or refractory acute promyelocytic leukaemia (APL) whose prior salvage treatment did not achieve the critical goal of second molecular remission, or who remain MRD-positive or refractory after that salvage line.
The preceding line targeted reinduction and consolidation in relapsed or refractory APL — using regimens such as ATO/ATRA, ATRA with chemotherapy, or, where chemotherapy was not suitable, gemtuzumab ozogamicin. The defining goal of that line was achievement of second molecular remission.
This protocol applies when second molecular remission was not reached, or when the patient is MRD-positive or refractory following salvage.
For patients who did achieve second molecular complete remission on salvage, a transplant-based consolidation approach is recommended. For those remaining MRD-positive or refractory, an alternative transplant strategy is preferred — and where transplant is not feasible, a targeted-agent-based regimen may be considered. The full decision pathway, eligibility criteria, and sequencing are in the complete protocol.
Patients relapsing after ATRA and ChT or relapsing >24 months after the end of ATO/ATRA treatment should receive ATO/ATRA for reinduction and consolidation until achievement of second molecular remission [IV, B].
For patients in second molecular CR, autoHCT is recommended for consolidation [IV, B].
For MRD-positive or refractory patients after salvage treatment, alloHCT is the preferred consolidation treatment.
If alloHCT is not feasible, treatment with GO, with or without ATO/ATRA, may be considered (Figure 5) [IV, C].
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