A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06661915
Phase
PHASE2
Status
Suspended

Conditions

  • Accelerated Phase Myeloproliferative Neoplasm
  • Blast Phase Myeloproliferative Neoplasm
  • Essential Thrombocythemia
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myeloproliferative Neoplasm, Not Otherwise Specified
  • Polycythemia Vera
  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo buccal swab and blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Decitabine and Cedazuridine — DRUG
    Given PO
  • Iadademstat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (ASTX727)
    Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo buccal swab sample collection at baseline and blood sample collection and bone marrow aspiration and biopsy throughout the study.
  • Experimental: Arm II (ASTX727, iadademstat)
    Patients receive ASTX727 PO QD on days 1-5 and iadademstat PO QD on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo buccal swab sample collection at baseline and blood sample collection and bone marrow aspiration and biopsy throughout the study.

Primary Outcome Measure

Acute leukemia response-complete (ALR-C) rate [ Time Frame: Within 4 cycles (cycle length = 28 days) ]

Locations (31)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Coral SpringsCoral SpringsFlorida33065-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
UM Sylvester Comprehensive Cancer Center at DoralDoralFlorida33166-
UM Sylvester Comprehensive Cancer Center at HollywoodHollywoodFlorida33021-
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
University of Miami Sylvester Comprehensive Cancer Center at Sole MiaNorth MiamiFlorida33181-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Moffitt Cancer CenterTampaFlorida33612-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
UC Comprehensive Cancer Center at Silver CrossNew LenoxIllinois60451-
University of Chicago Medicine-Orland ParkOrland ParkIllinois60462-
UChicago Medicine Northwest IndianaCrown PointIndiana46307-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Atrium Health Cabarrus/LCI-ConcordConcordNorth Carolina28025-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health and Science UniversityPortlandOregon97239-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in Irvine, CA

By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAStanford Cancer Institute Palo Alto· Palo Alto, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Coral Springs· Coral Springs, FL

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