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 Cohort 1A To evaluate the safety of ropeginterferon monotherapy and to determine the recommended phase 2 dose (RP2D) of ropeginterferon in patients with R/R MDS/AML with ≥5% blasts Cohort 1B To evaluate the safety and determine the RP2D of ropeginterferon in combination with AZA in patients with newly diagnosed MDS/AML with ≥10% blasts Secondary Objectives To observe and record anti-tumor activity. Although the clinical benefit of ropeginterferon has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the…
Eligibility Criteria Participants with following: I) Adult participants with MDS/AML 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 or possible pathogenic missense, truncating or splicing mutations in the UT MD Anderson CLIA lab myeloid NGS panel and validated by molecular pathologist; TP53 allele loss on FISH should be at least \> 5%) a. Cohort1A: R/R MDS…
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