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
Single group
ropeginterferon alfa- 2b
DrugGiven by iv
Azacitidine (AZA)
DrugGiven by IV
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
PharmaEssentia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
