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.
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 with MDS/AML without a known pathogenic TP53 mutation
Treated secondary AML (AML developing after prior exposure to hypomethylating agents, chemotherapy or allogeneic HSCT for previous myeloid disorders like MDS, CMML, other MDS/MON overlap syndromes)
Post MPN AML (advanced phase MPN)
Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
M.D. Anderson Cancer Center
Lead sponsor
PharmaEssentia
Collaborator