Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Daiichi Sankyo
Study ID
NCT06578247
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Quizartinib — DRUG
    Participants will receive quizartinib at 60 mg/day orally once daily
  • Placebo — DRUG
    Participants will receive placebo at 60 mg/day orally once daily
  • Chemotherapy — DRUG
    Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Study Details

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Key Dates

Start date
Nov 19, 2024
Status verified
Apr 2026
Primary completion
Jun 26, 2030
Completion
Jun 26, 2030

Study Design

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

Arms

  • Experimental: Arm A: Quizartinib + Chemotherapy
    Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
  • Placebo Comparator: Arm B: Placebo + Chemotherapy
    Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
  • Experimental: Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
    Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Primary Outcome Measure

Overall Survival (Arm A vs Arm B) [ Time Frame: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months ]

Central Contacts

Locations (53)

FacilityCityStateZIPSite coordinators
City of Hope PhoenixGoodyearArizona85338-
Mayo Clinic - PhoenixPhoenixArizona85054-
University of Arizona Cancer CenterTucsonArizona85724-
David Geffen School of MedicineLos AngelesCalifornia90095-
University of California Davis Health SystemSacramentoCalifornia95817-
Ucsf - School of MedicineSan FranciscoCalifornia94115-
Stanford University School of Medicine- ParentStanfordCalifornia94305-
Colorado Blood Cancer InstituteDenverColorado80218-
Yale UniversityNew HavenConnecticut06510-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Mayo Clinic HospitalJacksonvilleFlorida32224-
Florida Hospital Cancer Institute - KissimmeeKissimmeeFlorida34741-
Moffitt Cancer CenterTampaFlorida33612-
Tampa General HospitalTampaFlorida33606-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Augusta UniversityAugustaGeorgia30912-
Robert H Lurie Comprehensive Cancer Center Northwestern UniversityChicagoIllinois60611-
The University of Chicago Medical CenterChicagoIllinois60637-
University of Illinois Hospital & Health Sciences SystemChicagoIllinois60612-
University of KentuckyLexingtonKentucky40504-
Ochsner Medical Center - New OrleansNew OrleansLouisiana70121-
Johns Hopkins HospitalBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
University of Michigan Comprehensive Cancer Center Michigan MedicineAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
University of Minnesota Medical School - Twin Cities CampusMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55902-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Thomas Jefferson Univ HospHaddonfieldNew Jersey08033-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Memorial Sloan Kettering Cancer Center - MainLong Island CityNew York11101-
Memorial Sloan Kettering Cancer Center - MainNew YorkNew York10065-
Upstate University HospitalSyracuseNew York13210-
University of North Carolina HospitalsChapel HillNorth Carolina27514-
Duke Cancer Institute - Sarcoma ResearchDurhamNorth Carolina27710-
University of CincinnatiCincinnatiOhio45219-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
Ohio Health Marion Area PhysiciansColumbusOhio43214-
The James Cancer Hospital and Solove Research InstituteColumbusOhio43210-
Peggy & Charles Stephenson Oklahoma Cancer CtrOklahoma CityOklahoma73104-
Oregon Health & Science University (Ohsu)PortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Upmc Hillman Cancer CenterPittsburghPennsylvania15232-
Rhode Island HospitalProvidenceRhode Island02903-
Tristar Bone Marrow TransplantNashvilleTennessee37203-
South Austin Medical CenterAustinTexas78745-
Houston Methodist HospitalHoustonTexas77030-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-
Uva Health SystemCharlottesvilleVirginia22908-
Virginia Commonwealth University (Vcu) Massey Cancer CenterRichmondVirginia23229-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Goodyear, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Phoenix· Goodyear, AZMayo Clinic - Phoenix· Phoenix, AZUniversity of Arizona Cancer Center· Tucson, AZDavid Geffen School of Medicine· Los Angeles, CAUniversity of California Davis Health System· Sacramento, CAUcsf - School of Medicine· San Francisco, CA

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