Actively Recruiting
Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia
Led by OHSU Knight Cancer Institute · Updated on 2025-08-12
24
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older without bias to gender, race, or ethnicity
- Able to understand the study and provide written informed consent
- Newly diagnosed, untreated AML based on WHO 2008 definitions and ineligible for intensive chemotherapy
- Intermediate- or adverse-risk AML as defined by European Leukemia Network 2022 criteria
- AML/MDS overlap cases with 10-19% bone marrow or peripheral blood blasts considered
- ECOG performance status of 2 or less for patients aged 75 years or older at consent
- Total bilirubin less than or equal to 1.5 times the upper limit of normal for patients aged 75 years or older
- Creatinine clearance of 60 mL/min or higher
- Patients aged 18 to 74 years with ECOG performance status up to 3 and at least one qualifying comorbidity
- Ability to swallow oral medications
- No ongoing anticoagulation or antiplatelet therapy within 14 days before starting treatment
- No history of severe bleeding disorders or recent major bleeding events
- White blood cell count less than 20 x 10^9/L prior to study start, with allowed cytoreduction
- Liver enzymes AST or ALT less than or equal to 2 times institutional upper limit of normal
- Willing to follow study schedule and lifestyle restrictions
- Able to provide bone marrow samples
- Accept supportive care including transfusions
- Negative pregnancy test within 72 hours before starting treatment for persons of childbearing potential
- Use of approved contraception from treatment start until 6 months after last dose for persons of childbearing potential and sperm-producing participants sexually active with them
You will not qualify if you...
- Prior allergic reaction to iadademstat, venetoclax, azacitidine, or any formulation ingredients
- Body weight less than 50 kg
- Use of investigational therapy within 5 half-lives or 28 days before starting treatment
- AML treatment within 14 days before starting treatment, except allowed cytoreduction
- Radiotherapy less than 14 days before starting treatment
- Major surgery within 28 days or stem cell transplant within 100 days before starting treatment
- Active treatment for graft-versus-host disease
- Another active cancer within 5 years before starting treatment unless approved by investigator
- Treatments targeting LSD1/KDM1A or BCL2 within 12 months before starting treatment
- Conditions limiting oral drug intake or absorption
- Use of monoamine oxidase inhibitors within 3 weeks before starting treatment
- Active central nervous system involvement with AML
- Uncontrolled infection or unstable medical conditions
- Active liver disease or positive hepatitis B or C status unless virus undetectable for 3 months
- HIV infection unless controlled and treatment compatible with study drugs
- Use of certain medications that affect venetoclax metabolism within specified timeframes
- Unwillingness to stop breastfeeding during study and 60 days after last dose
- Uncontrolled high blood pressure or poorly controlled diabetes
- Corrected QT interval over 450 ms at screening
- Psychiatric or social conditions limiting study compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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