A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations
Starting soon · Phase 1/Phase 2
Conditions studied: Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML
In brief
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.
Key facts
- Study ID
- NCT07646821
- Run by
- M.D. Anderson Cancer Center
- People needed
- 30
- Starts
- 2026-11-27
- Expected to finish
- 2030-12-11
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
- Participants with active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
- Participants with known and untreated major depressive disorder
- Participants with known and active autoimmune disorder
- Participants with known retinal disease except for known age related macular degeneration
- Participants with another active cancer warranting therapy. A maintenance therapy for a stable/treated prior cancer is acceptable if it does not interfere with the trial therapy. This needs to be discussed with the PI.
- Participants who are receiving any other leukemia treatment.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ropeginterferon alfa-2b, AZA or other agents used in study.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because AZA and potentially rIFN_A has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infant's secondary to treatment of the mother with the combination, breastfeeding should be discontinued if the mother is treated with combination. These potential risks may also apply to other agents used in this study.
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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