Clin2
NCT05907057Possibly a fitRecruiting

Ivosidenib plus azacitidine for newly diagnosed AML

Acute Myeloid Leukemia (AML)

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This trial studies ivosidenib together with azacitidine in people newly diagnosed with AML that has an IDH1 R132 gene mutation. It’s meant for patients who are not able to safely receive the strongest (intensive) chemotherapy, with the goal of improving control of the leukemia.

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

Phase
Phase 3
Enrollment
245 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have newly diagnosed, untreated AML (not previously treated, except limited temporary measures).
  • Your leukemia has an IDH1 R132 gene mutation, confirmed by testing.
  • You cannot safely receive intensive chemotherapy because of age (75+), limited activity (ECOG 2), or other serious health issues your doctor judges incompatible.
  • Your liver and kidney function meet the trial’s lab requirements.
  • If you could become pregnant, you must have a negative pregnancy test and use effective birth control during treatment and for at least 6 months after. If you have reproductive-partner risk, you must use effective birth control during treatment and for at least 3 months after.
  • You are not currently dealing with certain exclusions like uncontrolled infections, recent major heart problems, uncontrolled high blood pressure, or swallowing/stomach problems that affect oral medicine.

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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