OncoMatch/Clinical Trials/NCT06782542
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
Is NCT06782542 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Olutasidenib and Venetoclax for acute myeloid leukemia.
Treatment: Olutasidenib · Venetoclax · Azacitidine — The purpose of this study is as follows: 1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy treatment that people with this condition receive. 2. Determine how well the combination treatment of olutasidenib, venetoclax, and azacitidine works compared to the usual chemotherapy treatment that people with this condition receive.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 R132 mutation
Newly diagnosed AML Isocitrate dehydrogenase 1 (IDH1) R132 mutated disease as assessed locally
Excluded: FLT3 ITD mutation
Positive Fms related receptor tyrosine kinase 3-Internal tandem duplication (FLT3-ITD) mutation
Disease stage
Required: Stage NEWLY DIAGNOSED
Excluded: Stage RELAPSED, REFRACTORY
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: IDH1 inhibitor (olutasidenib, ivosidenib)
Previous therapy with olutasidenib (or ivosidenib or other IDH1 inhibitor)
Cannot have received: BCL-2 inhibitor (venetoclax)
Previous therapy with venetoclax (or another B cell lymphoma 2 (BCL-2) inhibitor)
Lab requirements
Kidney function
Creatinine clearance ≥30 mL/min (using Cockcroft-Gault), or serum creatinine ≤1.5 × ULN
Liver function
AST and ALT ≤3 × ULN or ≤5 × ULN for participants with leukemic involvement; Bilirubin ≤2 ULN (≤3 × ULN in participants with Gilbert Syndrome) or ≤3 × ULN for participants with leukemic involvement
Cardiac function
Baseline QTcF ≤ 480 msec (not applicable to participants with bundle branch block)
Participant must have adequate organ function, defined by the following: AST and ALT ≤3 × ULN or ≤5 × ULN for participants with leukemic involvement; Bilirubin ≤2 ULN (≤3 × ULN in participants with Gilbert Syndrome) or ≤3 × ULN for participants with leukemic involvement; Creatinine clearance ≥30 mL/min (using Cockcroft-Gault), or serum creatinine ≤1.5 × ULN. Baseline QTcF ≤ 480 msec.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06782542 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior IDH1 inhibitor, BCL-2 inhibitor disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 R132 mutation is a required biomarker for enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 ITD mutation is an exclusion criterion.
What disease stage is eligible?
Stage NEWLY DIAGNOSED is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages