Actively Recruiting
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Led by Medical College of Wisconsin · Updated on 2026-04-03
12
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome (MDS).
CONDITIONS
Official Title
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with myelodysplastic syndrome, MDS/myeloproliferative neoplasm, or chronic myelomonocytic leukemia per WHO criteria
- Intermediate, high, or very-high risk by the Revised International Prognostic Scoring System (IPSS-R)
- ECOG performance status of 0 to 2 (or 0 to 3 if due to MDS)
- Body weight of at least 50 kg
- White blood cell count below 30 x 10^9/L; hydroxyurea allowed to achieve this
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN); patients with Gilbert's syndrome allowed if conjugated bilirubin is normal
- AST and ALT less than or equal to 3 times ULN
- Serum creatinine less than or equal to 1.5 times ULN
- Able to swallow oral medications
- Female subjects must be postmenopausal for at least one year, surgically sterile, or if of childbearing potential, agree to use effective contraception or true abstinence and not donate or freeze eggs during the study and for 180 days after last dose
- Male subjects, including those surgically sterilized, must agree to use effective barrier contraception or true abstinence and not donate or freeze sperm during the study and for 180 days after last dose
- Able to provide informed consent or have a legally authorized representative provide consent
You will not qualify if you...
- Prior therapy with hypomethylating agents or LSD1 inhibitors; other KDM1A/LSD1 inhibitors allowed only if stopped at least 3 weeks before study
- Need for treatment with drugs targeting 5-HT2B or sigma receptors during study, except if essential with monitoring
- Systemic chemotherapy within 14 days or 5 half-lives before study start; radiation within 14 days before study start
- Use of investigational products within 3 weeks prior to first dose
- Major surgery within 4 weeks prior to first dose
- Uncontrolled hypertension (systolic >180 mm Hg or diastolic >95 mm Hg); controlled hypertension allowed
- Poorly controlled diabetes (HbA1c ≥8%) unless managed
- Active congestive heart failure NYHA class 3 or 4, or history of such unless left ventricular ejection fraction ≥40%
- Known long QT syndrome at screening
- Allogeneic stem cell transplant or CAR-T therapy within past 60 days
- Active uncontrolled infections making patient unstable
- Malabsorption due to prior GI surgery or disease affecting drug absorption
- Pregnant or breastfeeding women
- Any condition making patient unsuitable for study participation including serious medical or psychiatric conditions, dementia, or inability to consent
- Known contraindication to treatment drug components
- Active hepatic disorder or positive for hepatitis B or C with detectable viral load
- Known HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
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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