Study of Decitabine, Venetoclax, and Olutasidenib for IDH1-Mutated Myeloid Cancers

This study is testing a combination of three drugs: decitabine (given by IV or orally as decitabine/cedazuridine), venetoclax, and olutasidenib. Olutasidenib is a targeted inhibitor for the IDH1 gene mutation. The study aims to find a safe and effective dose of these drugs for people with specific blood cancers, including relapsed or refractory (meaning it came back or didn't respond to previous treatment) Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS). You can join if you are over 18 and have a documented IDH1 gene mutation. The main goal is to see how safe the drug combination is and how many people experience a complete or partial remission. The study plans to enroll 78 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 78 participants to determine the best dose and effectiveness of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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NCT06445959

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~78 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:OlutasidenibVenetoclaxDecitabineDecitabine/cedazuridine

At a glance

Recruiting sites
5 of 5 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.
Mutant IDH1 Inhibitor Olutasidenib
5 sites across 5 states
Florida1
Kansas1
Massachusetts1
New York1
Texas1
  • Courtney DiNardo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • 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