OncoMatch/Clinical Trials/NCT06661915
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
Is NCT06661915 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Decitabine and Cedazuridine and Iadademstat for accelerated phase myeloproliferative neoplasm.
Treatment: Decitabine and Cedazuridine · Iadademstat — This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative myeloproliferative neoplasms (MPNs). ASTX727 is a combination of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with iadademstat may be more effective than ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative MPNs.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myeloproliferative Neoplasm
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Excluded: IDH1 mutation
Patients with IDH1-mutated MPN blast phase (≥ 20% blasts). Patients with an IDH1-mutation with MPN-AP (10-19%) blasts are eligible for this study
Disease stage
Required: Stage ACCELERATED-PHASE (10-19% MYELOID BLASTS), BLAST-PHASE (≥ 20% MYELOID BLASTS) (other)
accelerated-phase (10-19% myeloid blasts) or blast-phase (≥ 20% myeloid blasts)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: DNMT inhibitor
Patients must not have received prior DNMTi
Lab requirements
Blood counts
Peripheral white blood cell (WBC) count < 25 x 10^9/L on day 1 prior to treatment initiation
Kidney function
Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 by MDRD
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (unless elevated due to Gilbert's syndrome, thought to be related to MPN-AP/BP, or due to extrasvascular hemolysis. In these cases conjugated bilirubin should be ≤ 2.0 x ULN); AST/ALT ≤ 3 x institutional ULN
Cardiac function
NYHA class II or better; QTcF ≤ 450 ms
Total bilirubin ≤ 1.5 x institutional ULN (unless elevated due to Gilbert's syndrome, thought to be related to MPN-AP/BP, or due to extrasvascular hemolysis. In these cases conjugated bilirubin should be ≤ 2.0 x ULN); AST/ALT ≤ 3 x institutional ULN; GFR ≥ 60 mL/min/1.73 m^2 by MDRD; Peripheral white blood cell (WBC) count < 25 x 10^9/L on day 1 prior to treatment initiation; NYHA class II or better; QTcF ≤ 450 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Stanford Cancer Institute Palo Alto · Palo Alto, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06661915 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior DNMT inhibitor disqualifies patients from enrollment.
Are patients with IDH1 alterations eligible?
No. IDH1 mutation is an exclusion criterion.
What disease stage is eligible?
Stage ACCELERATED-PHASE (10-19% MYELOID BLASTS) or BLAST-PHASE (≥ 20% MYELOID BLASTS) 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 qualify