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Not Yet Recruiting NCT07646821

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

Conditions: Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: M.D. Anderson Cancer Center

Location: MD Anderson Cancer Center Houston Texas

Summary

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.

Eligibility Criteria

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) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07646821). StuddyBuddy aggregates publicly available trial information.