A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations

Eligibility Criteria Participants with following: i) Adult participants (≥ 18 years) with newly diagnosed MDS/AML ≥ 10% blasts with TP53 aberration * TP53 aberration defined by: * Single TP53 mutation\> 10% VAF * ≥ 1 mutation of any VAF, irrespective of cytogenetics or TP53 allele loss * Single TP53 mutation 5-10% with complex karyotype and/or TP53 allele loss * (TP53 mutation will include any known pathogenic missense, truncating or splicing mutations (defined as Tier 1 or 2 in the UT MD Anderson CLIA lab myeloid NGS panel or validated by molecular pathologist; TP53 allele loss on FISH should be at least \> 5%) ii) Ineligible for intensive chemotherapy * Adult participants ≥ 60 years of age, OR * Adult participants 18 to 60 years of age with at least one of the following relevant clinical situations/status: * Eastern cooperative oncology group (ECOG) performance status ≥2 * Clinically significant organ comorbidities, as reflected by at least 1 of: * Left ventricular ejection fraction (LVEF) \</= 50% * Chronic stable angina or congestive heart failure controlled with medication * Creatinine clearance \< 45 ml/min calculated by the Cockcroft-Gault formula or measured by 24 hours' urine collection * Impaired pulmonary function: Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected * Forced expiratory volume in 1 second (FEV1) ≤65% of expected * Other contraindication(s) to anthracycline therapy (must be documented). …