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Recruiting
NCT07646821
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML 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 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/AML ≥ 18years of age, irrespective of eligibility of intensive therapy
i) ≥5% blasts in the bone marrow and/or peripheral blood.
b.Cohort1B: Newly diagnosed MDS/AML and Ineligible for intensive chemotherapy defined by: i) ≥ 10% blasts ii) Ineligible for intensive chemotherapy
* Adult patients ≥ 60 years of age, OR
* Adult patients 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) \
Source: ClinicalTrials.gov (NCT07646821). StuddyBuddy aggregates publicly available trial information.