OncoMatch/Clinical Trials/NCT06502145
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Is NCT06502145 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06502145 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hypomethylating agent, LSD1 inhibitor, systemic antineoplastic chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage INTERMEDIATE or HIGH or VERY-HIGH is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages