Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Kura Oncology, Inc.
Study ID
NCT07007312
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

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

Interventions

  • Ziftomenib — DRUG
    Oral administration
  • Placebo — DRUG
    Oral administration
  • Venetoclax — DRUG
    Oral administration
  • Azacitidine (AZA) — DRUG
    Intravenous or subcutaneous administration
  • Daunorubicin — DRUG
    Intravenous administration
  • Cytarabine (Ara-C) — DRUG
    Intravenous administration

Study Details

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Key Dates

Start date
Sep 26, 2025
Status verified
May 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nonintensive Therapy Study, Arm A
    Ziftomenib in combination with venetoclax+azacitidine
  • Placebo Comparator: Nonintensive Therapy Study, Arm B
    Placebo in combination with venetoclax+azacitidine
  • Experimental: Intensive Therapy Study, Arm A
    Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)
  • Experimental: Intensive Therapy Study, Arm B
    Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)
  • Placebo Comparator: Intensive Therapy Study, Arm C
    Placebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)

Primary Outcome Measure

Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS) [ Time Frame: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion ]

Central Contacts

Locations (42)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
University of California, FresnoClovisCalifornia93611-
University of California, San DiegoLa JollaCalifornia92093-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, IrvineOrangeCalifornia92868-
University of ColoradoAuroraColorado80045-
Colorado Blood Cancer InstituteDenverColorado80218-
Hartford HealthCare Cancer InstituteHartfordConnecticut06106-
Yale University School of MedicineNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Moffitt Cancer Center & Research InstituteTampaFlorida33612-
University of IowaIowa CityIowa52246-
University of KentuckyLexingtonKentucky40536-
University of MassachusettsWorcesterMassachusetts01605-
University of MichiganAnn ArborMichigan48109-
Wayne State University School of MedicineDetroitMichigan48201-
University of MinnesotaMinneapolisMinnesota55455-
Rutgers Biomedical and Health SciencesNew BrunswickNew Jersey08903-
University of New MexicoAlbuquerqueNew Mexico87131-
State University of New York at BuffaloBuffaloNew York14263-
Columbia UniversityNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10003-
Weill Cornell Medical CenterNew YorkNew York10065-
University of North Carolina, Chapel HillChapel HillNorth Carolina27514-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State UniversityColumbusOhio43210-
Willamette Valley Cancer InstituteEugeneOregon97401-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Baptist Clinical Research InstituteMemphisTennessee38120-
Tennessee OncologyNashvilleTennessee37203-
TriStar Centennial Medical CenterNashvilleTennessee37203-
Texas Oncology-Austin MidtownAustinTexas78705-
Texas Oncology-Presbyterian Cancer CenterDallasTexas75231-
University of TexasHoustonTexas77030-
Texas Oncology - San Antonio Medical CenterSan AntonioTexas78240-
University of Vermont Medical CenterBurlingtonVermont05401-
University of Virginia School of MedicineCharlottesvilleVirginia22903-
Virginia Cancer SpecialistsManassasVirginia20110-
WVU Medicine Wheeling HospitalWheelingWest Virginia26003-
University of WisconsinMadisonWisconsin53792-
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZUniversity of California, Fresno· Clovis, CAUniversity of California, San Diego· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, Irvine· Orange, CA

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