RecruitingMutant IDH1 Inhibitor Olutasidenib
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 1. Age \> 18 years
- ✓ 2. Participants must have a documented IDH1 gene mutation
- ✓ 3. Participants with a diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML), high-risk MDS by IPSS-R or IPSS-M; OR
- ✓ 4. Participants with newly diagnosed AML not eligible or appropriate for intensive chemotherapy are also eligible. (Phase 2 portion only)
- ✓ 5. To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years with at least one of the following comorbidities:
- ✓ 1. Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).
- ✓ 2. Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second \[FEV1\] ≤65%).
- ✓ 3. Creatinine clearance ≥30 mL/min to \<45 mL/min.
You may not qualify if…
- ✕ 1. Participants with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML).
- ✕ 2. Participants with any concurrent uncontrolled clinically significant medical condition including life-threatening severe infection, or psychiatric illness, which could place the participants at unacceptable risk of study treatment.
- ✕ 3. Participants with active, uncontrolled leukemia involvement of the CNS
- ✕ 4. Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant including active cGVHD requiring topic therapy. Patients must have discontinued calcineurin inhibitors at least 4 weeks prior to start of study treatment.
- ✕ 5. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- ✕ 6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
- ✕ 7. Participant has a white blood cell count \> 25 x 10\^9/L. (Note: Hydroxyurea and cytarabine is permitted to meet this criterion.)
- ✕ 8. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06445959 · last updated 2026-08-19