OncoMatch/Clinical Trials/NCT06357182
Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia
Is NCT06357182 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 the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as 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, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: ABL1 fusion
Excluded: BCR fusion
Performance status
ECOG 0–3(Limited self-care)
ECOG performance ≤ 2 (Patients aged ≥ 75 years, at the time of consent); Patients aged ≥ 18 to 74 years (ECOG performance status [PS] ≤ 3 is accepted) at consent must meet ≥ 1 of the following criteria defining a co morbidity
Prior therapy
Cannot have received: intensive chemotherapy induction
ineligible for standard of care (SOC) intensive chemotherapy induction
Cannot have received: investigational therapy
Investigational therapy within 5 half-lives or, if unknown, within 28 days prior to start of IADA
Cannot have received: AML therapy
Exception: cytoreduction with hydroxyurea or leukapheresis as specified in inclusion criteria
Treatment for AML within 14 days prior to start of IADA. Cytoreduction for patients with proliferative disease must meet the criteria listed in inclusion criteria
Cannot have received: radiotherapy
Radiotherapy less than 14 days prior to start of IADA
Cannot have received: stem cell transplant
stem cell transplant within 100 days prior to the start of IADA
Cannot have received: LSD1/KDM1A inhibitor
Treatments targeting or inhibiting LSD1/KDM1A within 12 months prior to the start of IADA
Cannot have received: BCL2 inhibitor
Treatments targeting or inhibiting ... BCL 2 within 12 months prior to the start of IADA
Cannot have received: monoamine oxidase inhibitor (tranylcypromine)
Treatment with monoamine oxidase inhibitors (e.g., tranylcypromine), if treatment is not finalized at least 3 weeks prior to the start of IADA
Lab requirements
Blood counts
White blood cell (WBC) < 20 x 10^9/L prior to study start
Kidney function
Creatinine clearance (CrCl) of ≥ 60 mL/min (≥75 years); CrCl ≥ 30 mL/min to < 45 ml/min (18-74 years with comorbidity)
Liver function
Total bilirubin ≤ 1.5 x ULN (≥75 years); moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN (18-74 years with comorbidity); AST/ALT ≤ 2.0 x institutional ULN
Cardiac function
Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina; mean of triplicate corrected QT interval (QTcF) > 450 ms at Screening based on central reading [excluded]
Total bilirubin ≤ 1.5 x ULN (≥75 years); moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN (18-74 years with comorbidity); AST/ALT ≤ 2.0 x institutional ULN; Creatinine clearance (CrCl) of ≥ 60 mL/min (≥75 years); CrCl ≥ 30 mL/min to < 45 ml/min (18-74 years with comorbidity); White blood cell (WBC) < 20 x 10^9/L prior to study start; Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina; mean of triplicate corrected QT interval (QTcF) > 450 ms at Screening based on central reading [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
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