Patient has NOT previously received an HDAC inhibitor (vorinostat, romidepsin, belinostat...

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

ID	`RF-PRIOR-HDACI-NAIVE`
Type	Red flag
Status	reviewed 2026-04-27 \| pending_clinical_signoff
Diseases	None declared
Sources	`SRC-ESMO-CTCL-2024` `SRC-ESMO-PTCL-2024` `SRC-NCCN-BCELL-2025`

Red Flag Origin

Definition	Patient has NOT previously received an HDAC inhibitor (vorinostat, romidepsin, belinostat, panobinostat, chidamide). Used as eligibility gate for HDACi-based 2L/3L regimens in PTCL (romidepsin Coiffier 2012, ORR 25-38%; belinostat BELIEF/Lee 2015, ORR 25%) and CTCL (vorinostat ZOLINZA 2007). Firing means HDACi-route remains open. Co-fires with disease-specific PTCL/CTCL flags to define the salvage algorithm branch.
Clinical direction	intensify
Category	other

Trigger Logic

{
  "any_of": [
    {
      "finding": "prior_hdaci_received",
      "value": false
    },
    {
      "finding": "prior_hdac_inhibitor_received",
      "value": false
    },
    {
      "finding": "hdaci_naive",
      "value": true
    },
    {
      "finding": "prior_therapy_classes",
      "value": "no_hdaci"
    }
  ],
  "type": "composite_score"
}

Notes

Eligibility-gate flag for PTCL/CTCL salvage. PTCL: HDACi (romidepsin/ belinostat) ORR 25-38%, mDOR 9-15 mo, single-agent — used at 2L+ in non-AITL PTCL when BV (ECHELON-2) was not part of 1L. AITL has particular HDACi sensitivity (romidepsin AITL ORR ~50%). CTCL/MF/SS: vorinostat (ORR 30%) and romidepsin (ORR 34%) — used 2L+ for refractory disease, especially erythrodermic SS. Ro-CHOP (Ro+CHOP) was tested 1L (Ro-CHOP, Bachy 2022) and did NOT improve PFS over CHOP — HDACi belongs at 2L+, not 1L. Class toxicity: thrombocytopenia, neutropenia, fatigue, GI; QT-prolongation (romidepsin → ECG monitoring). Romidepsin USA-withdrawn for PTCL 2021 (post-marketing trial failed to confirm 1L benefit) but EMA-approved and active 2L+. Access UA: romidepsin not NSZU-listed; chidamide (China-developed, EMA-pending) not available.

Used By

Algorithms

ALGO-PTCL-2L - ALGO-PTCL-2L