OncoMatch/Clinical Trials/NCT06502145
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Is NCT06502145 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for myelodysplastic syndromes.
Treatment: Azacitidine Level -1 · Azacitidine Level 0 · Azacitidine Level 1 · Iadademstat Level -1 · Iadademstat Level 0 · Iadademstat Level 1 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage INTERMEDIATE, HIGH, VERY-HIGH (IPSS-R)
Intermediate, high, or very-high risk by the Revised International Prognostic Scoring System (IPSS-R).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: hypomethylating agent
Prior therapy with hypomethylating agent
Cannot have received: LSD1 inhibitor
Exception: If patients were treated with any other agents having KDM1A/LSD1 inhibitory activity (such as tranylcypromine or phenelzine or similar drugs), they are only allowed if treatment finalized at least 3 weeks prior to first dose on study.
Prior therapy with Lysine-specific histone demethylase 1A (LSD1) inhibitor. If patients were treated with any other agents having KDM1A/LSD1 inhibitory activity (such as tranylcypromine or phenelzine or similar drugs), they are only allowed if treatment finalized at least 3 weeks prior to first dose on study.
Cannot have received: systemic antineoplastic chemotherapy
Exception: within 14 days or 5 half-lives from the last dose - whichever is sooner - before Cycle 1, Day 1 of therapy
Treatment with systemic antineoplastic chemotherapy within 14 days or 5 half-lives from the last dose - whichever is sooner - before Cycle 1, Day 1 of therapy
Cannot have received: radiation therapy
Exception: within 14 days before Cycle 1, Day 1 of therapy
Radiation within 14 days before Cycle 1, Day 1 of therapy
Cannot have received: investigational product
Exception: within 3 weeks prior to the first dose of study treatment
Patient is on treatment with any investigational products within 3 weeks prior to the first dose of study treatment.
Cannot have received: allogeneic stem cell transplantation
Exception: within past 60 days
History of allogeneic stem cell transplantation or CAR-T therapy within past 60 days.
Cannot have received: CAR-T cell therapy
Exception: within past 60 days
History of allogeneic stem cell transplantation or CAR-T therapy within past 60 days.
Lab requirements
Blood counts
WBC below 30 x 10^9/L (hydroxyurea can be used to achieve this level)
Kidney function
Serum creatinine ≤1.5 x ULN
Liver function
Total bilirubin ≤1.5 x ULN (Gilbert's syndrome allowed if conjugated bilirubin is within normal limits); AST and ALT ≤3 x ULN
Hematologic: white blood cell (count) (WBC) below 30 x 10^9/L. Hydroxyurea can be used to achieve this level b. Hepatic: i. Total bilirubin ≤1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits. ii. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN. c. Renal: Serum creatinine ≤1.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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