Phase 2 Study of Olutasidenib for IDH1-Mutated Blood Disorders

This study is testing a drug called olutasidenib to see if it can help people with certain blood disorders: Clonal Cytopenia of Undetermined Significance (CCUS), Myelodysplastic Syndromes (MDS), and Chronic Myelomonocytic Leukemia (CMML). You may be able to join if you have one of these conditions and your disease has a specific genetic change called an IDH1 mutation. Researchers want to find out how well olutasidenib works to control these conditions and if it is safe. Success would mean seeing a good response to the treatment, like needing fewer blood transfusions. This study plans to enroll 15 participants, but the current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study, with 15 planned participants.
What's involved
You would take olutasidenib by mouth twice daily in 28-day cycles. You will also have blood samples and bone marrow procedures. Patients with CCUS receive treatment for up to 18 months, while those with MDS/CMML continue until the disease worsens or side effects are too much.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will be followed up every 3 months for up to 3 years.

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NCT06566742

A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~15 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Olutasidenib

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Clonal Cytopenia of Undetermined Significance
2 sites across 2 states
Florida1
Texas1
  • Kelly Chien, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

Note: hydroxyurea use is permitted to meet this criterion with no washout required. 6. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care.
  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0