Clin2
NCT06616636Possibly a fitRecruiting

Rezatapopt and azacitidine for AML or MDS with a specific TP53 mutation

Myelodysplastic SyndromeAcute Myeloid Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This trial tests a new drug, rezatapopt, combined with azacitidine for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back or not responded to treatment. It is only for people whose cancer cells have a specific change in a gene called TP53 (the Y220C mutation). The goal is to see if this combination can help control the disease.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
24 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 or older.
  • You must have acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after treatment (relapsed) or did not respond to prior treatment (refractory).
  • Your cancer cells must have a specific change in the TP53 gene called Y220C. This must be confirmed by a standard lab test, and the change must be present in more than 2% of the cells tested.
  • You must be able to take care of yourself and be up and about at least half of the day (ECOG score 0-2).
  • Your liver and kidney function must be within certain limits, as determined by blood tests.
  • If you could become pregnant, you must have a negative pregnancy test and agree to use effective birth control during the study and for a few months after.
  • You cannot have received certain cancer treatments within 14 days before starting the study drugs.
  • You cannot have certain active infections (like HIV, hepatitis B or C) or other serious medical conditions that would make the study unsafe.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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