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NCT07153497Possibly a fitNot yet recruiting

Olutasidenib for IDH1-Mutated AML and MDS

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This trial tests a targeted drug, olutasidenib, for people with AML or MDS whose cancer cells have an IDH1-R132 mutation. Depending on your specific diagnosis, you may receive olutasidenib alone or combined with other medicines.

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

Phase
Phase 2
Enrollment
132 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must have a specific IDH1-R132 mutation in your cancer cells, detected through the MyeloMATCH master screening.
  • For AML (Cohort A): You must be 60 or older, or younger if unable to tolerate intensive chemotherapy, with at least 20% blasts in marrow or blood.
  • For high-risk MDS (Cohort B): You must be 18 or older, have newly diagnosed high-risk MDS with an IPSS-R score of 4.0 or higher, and have not had prior treatment except for certain growth factors.
  • For low-risk MDS (Cohort C): You must be 18 or older, with low-risk MDS (IPSS-R score 3.5 or less) and have anemia requiring transfusions or low blood counts, and have not had prior hypomethylating agents.
  • You must have good kidney and liver function, with creatinine clearance at least 30 mL/min and bilirubin no more than 3 times the upper limit of normal.
  • You must be able to swallow pills and not have uncontrolled gastrointestinal problems that could affect drug absorption.

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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