M.D. Anderson Cancer Center
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.
Primary Objectives To evaluate the safety and to determine the recommended phase 2 dose of rope interferon in combination with AZA.
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 F…
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