A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06852222
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

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

Interventions

  • Bleximenib — DRUG
    Bleximenib will be administered orally.
  • Venetoclax (VEN) — DRUG
    VEN will be administered orally.
  • Azacitidine (AZA) — DRUG
    AZA will be administered intravenously or subcutaneously.
  • Placebo — DRUG
    Placebo will be administered orally.

Study Details

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Key Dates

Start date
Jun 4, 2025
Status verified
Jun 2026
Primary completion
Jun 22, 2029
Completion
Aug 15, 2029

Study Design

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

Arms

  • Experimental: Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)
    Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.
  • Placebo Comparator: Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)
    Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants who Achieve Complete Remission (CR) [ Time Frame: Up to 4 years and 1 month ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Cancer Treatment Center of America PhoenixGoodyearArizona85338-
The University of Arizona Cancer CenterTucsonArizona85724-
University of Arkansas at Little RockLittle RockArkansas72204-
City of HopeDuarteCalifornia91010-
Rocky Mountain Cancer CentersAuroraColorado80012-
Medical Oncology Hematology Consultants, PANewarkDelaware19713-
Florida Cancer Specialists & Research InstituteFort MyersFlorida33901-
Jupiter ResearchJupiterFlorida33458-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Moffit Cancer centerTampaFlorida33612-
Cleveland Clinic FloridaWestonFlorida33331-
University of Chicago MedicineChicagoIllinois60637-
Illinois Cancer SpecialistsNilesIllinois60714-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40207-
UofL Health Brown Cancer CenterLouisvilleKentucky40202-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Henry Ford Health SystemDetroitMichigan48202-
Trinity Health Michigan Heart - Ann Arbor CampusYpsilantiMichigan48106-
Washington University in St LouisSt LouisMissouri63130-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
New York Presbyterian - Weill CornellNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
Einstein-Montefiore Medical CenterThe BronxNew York10467-
Atrium HealthCharlotteNorth Carolina28204-
Carolina Oncology SpecialistsCharlotteNorth Carolina28207-
Novant Health CharlotteCharlotteNorth Carolina28204-
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Novant Health Winston SalemWinston-SalemNorth Carolina27106-
Gabrail Cancer CenterCantonOhio44718-
Oncology Hematology CareCincinnatiOhio45226-
Cleveland ClinicClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Providence Oncology and Hematology Care Clinic WestsidePortlandOregon97225-
Providence Portland Medical CenterPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15260-
University of TennesseeKnoxvilleTennessee37920-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
Baylor University Medical CenterDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - NortheastTylerTexas75702-
Virginia Commonwealth University - Massey Cancer CenterRichmondVirginia23298-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCancer Treatment Center of America Phoenix· Goodyear, AZThe University of Arizona Cancer Center· Tucson, AZUniversity of Arkansas at Little Rock· Little Rock, ARCity of Hope· Duarte, CARocky Mountain Cancer Centers· Aurora, CO

Related Studies