AML eligible for CPX-351 (Vyxeos) liposomal cytarabine+daunorubicin per the FDA-approved...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

ID	`RF-AML-SECONDARY-AML-MRC-CPX351-ELIGIBLE`
Type	Red flag
Status	reviewed 2026-05-01 \| pending_clinical_signoff
Diseases	`DIS-AML`
Sources	`SRC-ELN-AML-2022` `SRC-NCCN-AML-2025`

Red Flag Origin

Definition	AML eligible for CPX-351 (Vyxeos) liposomal cytarabine+daunorubicin per the FDA-approved subset: therapy-related AML (t-AML, post-cytotoxic / post-radiation), AML with myelodysplasia-related changes (AML-MRC) per WHO criteria (multilineage dysplasia OR MDS-related cytogenetics OR antecedent MDS/CMML). Phase-3 Lancet 2018 (Lancet 2018;392:2088; Lancet Haematology 2020;7:e552 5-yr follow-up): mOS 9.56 vs 5.95 mo for 7+3, HR 0.69; 5-yr OS 18% vs 8%. Eligibility window age 60-75 + fit-for-intensive-chemo. Routes 1L AML to CPX-351-SECONDARY indication over standard 7+3 when this RF fires.
Clinical direction	intensify
Category	high-risk-biology
Shifts algorithm	ALGO-AML-1L

Trigger Logic

{
  "any_of": [
    {
      "finding": "therapy_related_aml",
      "value": true
    },
    {
      "finding": "antecedent_mds",
      "value": true
    },
    {
      "finding": "antecedent_cmml",
      "value": true
    },
    {
      "finding": "aml_mrc",
      "value": true
    },
    {
      "finding": "aml_secondary",
      "value": true
    },
    {
      "finding": "aml_with_mds_related_changes",
      "value": true
    }
  ],
  "type": "composite_score"
}

Notes

Distinguish from RF-AML-HIGH-RISK-BIOLOGY (broader ELN-adverse category — includes TP53, complex karyotype, FLT3-ITD-no-NPM1, etc.): this flag is the CPX-351-eligibility-specific subset. Both can fire for the same patient; algorithm gates CPX-351 step BEFORE high-risk fall-through to 7+3 so CPX-351 takes precedence when applicable. Age constraint (60-75) + fitness gate live in IND-AML-1L-CPX351-SECONDARY.applicable_to.demographic_constraints — engine track-filter drops the indication for out-of-range patients. Pre-existing engine routing for unfit patients (step 2 → ven+aza) is preserved.

Used By

Algorithms

ALGO-AML-1L - ALGO-AML-1L