A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT07623200
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Essential Thrombocythemia

Eligibility Criteria

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

Interventions

  • INCA033989 — DRUG
    Administered intravenous (IV) in accordance with the protocol-defined requirements.
  • Best Available Treatment — DRUG
    Best Available Therapy (BAT) will be selected by the investigator.

Study Details

This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.

Key Dates

First listed
Jun 3, 2026
Start date
Sep 8, 2026
Status verified
Aug 2026
Primary completion
Jun 15, 2029
Completion
Nov 1, 2030

Study Design

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

Arms

  • Experimental: INCA033989
    Administered intravenous (IV) in accordance with the protocol-defined requirements.
  • Experimental: Best Available Therapy (BAT)
    Best Available Therapy (BAT) will be selected by the investigator.

Primary Outcome Measure

Durable clinicohematologic response (DCR) [ Time Frame: Week 24 ]

Central Contacts

Locations (44)

FacilityCityStateZIPSite coordinators
Banner Md Anderson Cancer CenterGilbertArizona85234-
The University of Arizona Cancer CenterTucsonArizona85724-5024-
City of Hope Medical CenterDuarteCalifornia91010-
Marin Cancer CareGreenbraeCalifornia94904-
University of California, Los Angeles Medical CenterLos AngelesCalifornia90095-
Stanford Cancer CenterPalo AltoCalifornia94304-
UCSFSan FranciscoCalifornia94143-
Rocky Mountain Cancer Centers-Lone TreeLone TreeColorado80124-
Medstar Georgetown Medical Center, IncWashington D.C.District of Columbia20007-
Florida Cancer Specialists & Research InstituteFort MyersFlorida33901-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Cleveland ClinicWestonFlorida33331-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
The University of Kansas Cancer CenterWestwoodKansas66205-
Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Beth Israel Deaconess Medical Center (Bidmc)BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant ClinicAnn ArborMichigan48109-4000-
Missouri Cancer AssociatesColumbiaMissouri65201-
Washington University School of MedicineSt LouisMissouri63110-
John Theurer Cancer Center, Hackensack University Medical CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Icahn School of Medicine At Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical College - Newyork-Presbyterian HospitaNew YorkNew York10065-
Strong Memorial Hospital University of Rochester Medical CenterRochesterNew York14642-
University of North Carolina Unc Medical Center North Carolina Womens Hospital Nc Womens HospitalChapel HillNorth Carolina27514-
Duke University Medical CenterDurhamNorth Carolina27705-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cleveland Clinic Taussig Cancer CtrClevelandOhio44195-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Oregon Health and Science UniversityPortlandOregon97239-
Thomas Jefferson University Sidney Kimmel Medical CollegePhiladelphiaPennsylvania19107-
Vanderbilt University Medical CenterNashvilleTennessee37232-5735-
Vanderbilt University Medical CenterNashvilleTennessee37232-
The University of Texas-Md Anderson Cancer CenterHoustonTexas77030-
Ut Health Science Center At San AntonioSan AntonioTexas78229-
Texas Oncology-TylerTylerTexas75702-
Huntsman Cancer Institute At University of UtahSalt Lake CityUtah84112-
University of Washington - Fred Hutch Cancer CenterSeattleWashington98109-

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By research site
Banner Md Anderson Cancer Center· Gilbert, AZThe University of Arizona Cancer Center· Tucson, AZCity of Hope Medical Center· Duarte, CAMarin Cancer Care· Greenbrae, CAUniversity of California, Los Angeles Medical Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CA

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