A Randomized Phase 2 Trial of ASTX727 +/- Iadademstat in Accelerated/Blast-Phase Philadelphia Chromosome-Negative Myeloproliferative Neoplasms (MPNs)

Clinical Trial Details

This 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. Iadademstat is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). This study aims to find out if this approach is better or worse than the usual approach for these myeloproliferative neoplasms.

Participants will be randomized into one of two study groups.

Group A
Participants in this group will take the usual treatment for this type of cancer, the drug ASTX727. The drug is taken as a tablet by mouth for the first five days of each cycle. Each cycle lasts 28 days.

Group B
Participants in this group will take the drug ASTX727, plus the study drug iadademstat. ASTX727 is taken as a tablet by mouth once per day for the first five days of each cycle and iadademstat is taken as a drinkable solution 5 days per week of each cycle. Each cycle lasts 28 days.

Key Eligibility:

Open to men and women ages ≥18 years.
Patients must have morphologically confirmed diagnosis of Philadelphia-chromosome negative MPN in accelerated-phase (10-19% myeloid blasts) or blast-phase (≥20% myeloid blasts) arising from polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, or MPN not otherwise specified, as per the WHO 2016 classification OR MDS/MPN overlap syndromes (e.g., CMML) with ≥10% blasts.

Detailed eligibility will be reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Ghaith Abu-Zeinah, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2510029414

ClinicalTrials.gov:

NCT06661915

Status

Open to Enrollment

Age Group

Adult

Disease

Myeloproliferative Neoplasms