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

NCT07646821 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

  • Ropeginterferon
  • Alfa-2b
  • Azacitidine
  • MDS/AML

Interventions

DRUG

ropeginterferon alfa- 2b

Given by iv

DRUG

Azacitidine (AZA)

Given by IV

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

  • PharmaEssentia

    collaborator INDUSTRY

Principal Investigators

  • Jayastu Senapati, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-27
Primary Completion
2028-12-11
Completion
2030-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646821 on ClinicalTrials.gov