A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Recruitment opened
    • Eligibility criteria expanded, about 15 words
    • Study title shortened, about 5 words
  2. Trial status: Not Yet Recruiting to Recruiting Show 4 more changesShow less
    • Start date: Nov 27, 2026 to Oct 27, 2026
    • Eligibility criteria expanded, about 134 words
    • Study description expanded, about 177 words
    • Site details revised
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07646821
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: PharmaEssentia
Conditions
(from sponsor)		 Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov