OncoMatch/Clinical Trials/NCT06514261
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML
Is NCT06514261 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and Iadademstat for acute myeloid leukemia.
Treatment: Azacitidine · Iadademstat · Venetoclax — This phase I trial tests safety, side effects and best dose of iadademstat with azacitidine and venetoclax for the treatment of patients with acute myeloid leukemia (AML) who have not received treatment (treatment naive). Chemotherapy drugs, such as iadademstat and azacitidine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe and tolerable in treating patients with treatment naive AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: intensive induction chemotherapy
Lab requirements
Blood counts
Peripheral white blood cell (WBC) count < 25 x 10^9/L on day 1 prior to treatment initiation. Hydroxyurea for up to 2 weeks is allowed for cytoreduction until 24 hours prior to study treatment
Kidney function
CKD-EPI GFR ≥ 40 mL/min/1.73 m^2
Liver function
Total bilirubin ≤ 1.5 x institutional ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN or ≤ 3 x ULN if patient has Gilbert's disease; AST/ALT ≤ 3 × institutional ULN or < 5 ULN if due to AML
Cardiac function
NYHA class II or better; patients with a troponin leak (i.e. elevated troponin levels at presentation without evidence of an active myocardial infarction) are eligible
Total bilirubin ≤ 1.5 x institutional ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN or ≤ 3 x ULN if patient has Gilbert's disease; AST/ALT ≤ 3 × institutional ULN or < 5 ULN if due to AML; CKD-EPI GFR ≥ 40 mL/min/1.73 m^2; Peripheral white blood cell (WBC) count < 25 x 10^9/L on day 1 prior to treatment initiation; NYHA class II or better; patients with a troponin leak (i.e. elevated troponin levels at presentation without evidence of an active myocardial infarction) are eligible
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of Cincinnati Cancer Center-UC Medical Center · Cincinnati, Ohio
- University of Pittsburgh Cancer Institute (UPCI) · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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