Oral azacitidine (CC-486 / Onureg) maintenance — AML CR1, transplant-ineligible (QUAZAR AML-001)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-AZACITIDINE |
|---|
| ID | REG-ORAL-AZA-QUAZAR-MAINTENANCE |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-27 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-NCCN-AML-2025 SRC-QUAZAR-WEI-2020 |
Notes
QUAZAR AML-001 (Wei 2020): oral azacitidine 300 mg PO daily × 14 d / 28-d cycle vs placebo as maintenance after CR/CRi post-induction ± consolidation in AML patients ≥55 years not eligible for HCT. mOS 24.7 vs 14.8 months (HR 0.69, p<0.001), mRFS 10.2 vs 4.8 months. FDA-approved Sep 2020 as Onureg. Critical: oral CC-486 is NOT bioequivalent to SC/IV azacitidine — only the oral formulation has this maintenance indication. Ukraine access major barrier (not registered as Onureg). STUB — requires Clinical Co-Lead signoff.
Used By
Indication
IND-AML-CR1-ORAL-AZA-MAINTENANCE- IND-AML-CR1-ORAL-AZA-MAINTENANCE