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O estudo clínico NCT07007312 para Leucemia Mieloide Aguda (LMA) está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML Fase III 1.300 Duplo-cego

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07007312 procura avaliar tratamento para Leucemia Mieloide Aguda (LMA). Este é um estudo intervencionista de Fase III. Seu status atual é: em recrutamento. O estudo começou em 26 de setembro de 2025 e pretende incluir 1.300 participantes. Coordenado por Kura Oncology e deve ser concluído em 1 de novembro de 2031. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de março de 2026.
Resumo
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 mutatio...

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Descrição detalhada
This protocol encompasses two phase 3, randomized, double-blind, placebo-controlled clinical studies to assess the efficacy, safety, and tolerability of ziftomenib in combination with: (a) the standard of care (SOC) nonintensive regimen (venetoclax \[ven\]+azacitidine \[aza\]) in untreated adults with nucleophosmin 1 mutated (NPM1-m) acute myeloid leukemia (AML); or (b) the SOC intensive regimen (cytarabine+daunorubi...Mostrar mais
Título oficial

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Condições médicas
Leucemia Mieloide Aguda (LMA)
Outros IDs do estudo
  • KO-MEN-017
  • 2025-521314-25-00 (Número CTIS (UE))
Número NCT
Data de início (real)
2025-09-26
Última atualização postada
2026-03-13
Data de conclusão (estimada)
2031-11
Inscrição (estimada)
1.300
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Em recrutamento
Palavras-chave
AML
Hematological malignancy
KMT2A
NPM1
Menin
Acute Leukemia
Leukemia
Acute Myeloid Leukemia
Newly diagnosed AML
Newly diagnosed KMT2A-r AML
Newly diagnosed NPM1m AML
Untreated AML
Untreated NPM1m AML
Untreated KMT2A-r AML
MLL
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Quádruplo-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalNonintensive Therapy Study, Arm A
Ziftomenib in combination with venetoclax+azacitidine
Ziftomenib
Oral administration
Venetoclax
Oral administration
Azacitidine (AZA)
Intravenous or subcutaneous administration
Comparador placeboNonintensive Therapy Study, Arm B
Placebo in combination with venetoclax+azacitidine
PLACEBO
Oral administration
Venetoclax
Oral administration
Azacitidine (AZA)
Intravenous or subcutaneous administration
ExperimentalIntensive Therapy Study, Arm A
Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)
Ziftomenib
Oral administration
Daunorubicin
Intravenous administration
Cytarabine (Ara-C)
Intravenous administration
ExperimentalIntensive Therapy Study, Arm B
Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)
Ziftomenib
Oral administration
PLACEBO
Oral administration
Daunorubicin
Intravenous administration
Cytarabine (Ara-C)
Intravenous administration
Comparador placeboIntensive Therapy Study, Arm C
Placebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)
PLACEBO
Oral administration
Daunorubicin
Intravenous administration
Cytarabine (Ara-C)
Intravenous administration
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)
OS
Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion
Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR)
CR rate per European Leukemia Network (ELN) 2022 criteria per Investigator assessment
Assessed up to 36 months after last patient inclusion
Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS)
EFS
Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion
Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients
CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity
Assessed up to 36 months after last patient inclusion
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Nonintensive Therapy Study: (EU & EU reference countries only): Complete remission (CR)
CR rate per ELN 2022 criteria per Investigator assessment
Up to 36 months after last patient inclusion
Nonintensive Therapy Study: Bone marrow (BM) measurable residual disease (MRD) negativity
Central BM MRD negativity rate
Up to 36 months after last patient inclusion
Nonintensive Therapy Study: Complete remission (CR) + complete remission with partial hematologic recovery (CRh)
CR + CRh rate per ELN 2022 criteria per Investigator assessment
Up to 36 months after last patient inclusion
Nonintensive Therapy Study: Descriptive statistics of Adverse Events (AEs)
Assessed by NCI-CTCAE v5.0
From start of treatment to 28 days from last dose of ziftomenib or placebo
Nonintensive Therapy Study: Area under the concentration-time curve (AUC) of ziftomenib and venetoclax
To characterize the AUC of ziftomenib and venetoclax
During treatment for up to 36 months after last patient inclusion
Nonintensive Therapy Study: Trough concentration (Ctrough) of ziftomenib and venetoclax
To characterize the Ctrough of ziftomenib and venetoclax
During treatment for up to 36 months after last patient inclusion
Nonintensive Therapy Study: Health-related patient-reported outcomes (PRO) assessments
Health-related quality of life (HRQoL) was evaluated by EORTC QLQ-C30 global health status/quality of life composite scale in all randomized participants. The QLQ-C30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicated better quality of life (QoL), while higher scores on the symptom scales indicated declining QoL.
Up to 36 months after last patient inclusion
Intensive Therapy Study: (EU & EU reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients
CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity
Up to 36 months after last patient inclusion
Intensive Therapy Study: Overall survival (OS)
OS
Defined as the time from randomization to date of death from any cause, up to 36 months after last patient inclusion
Intensive Therapy Study: Descriptive statistics of Adverse Events (AEs)
Assessed by NCI-CTCAE v5.0
From start of treatment to 28 days from last dose of ziftomenib or placebo
Intensive Therapy Study: Health-related patient-reported outcomes (PRO) assessments
Health-related quality of life (HRQoL) was evaluated by EORTC QLQ-C30 global health status/quality of life composite scale in all randomized participants. The QLQ-C30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicated better quality of life (QoL), while higher scores on the symptom scales indicated declining QoL.
Up to 36 months after last patient inclusion
Intensive Therapy Study: Area under the concentration-time curve (AUC) of ziftomenib
To characterize the AUC of ziftomenib
During treatment for up to 36 months after last patient inclusion
Intensive Therapy Study: Trough concentration (Ctrough) of ziftomenib
To characterize the Ctrough of ziftomenib
During treatment for up to 36 months after last patient inclusion
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos

The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:

  • Age ≥18 years at time of signing the informed consent form.

  • Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  • Adequate liver and kidney function according to protocol requirements.

  • A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention.

  • NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):

    1. Documented NPM1-m.

    2. Patients considered ineligible for Intensive Therapy defined by the following:

      • i. Age ≥75, OR
      • ii. Age <75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.
  • INTENSIVE THERAPY STUDY ONLY (7+3):

    1. Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).
    2. Documented FLT3 wild-type or ITD ratio <0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered "ineligible" for FLT3-targeted therapy.
    3. Ejection fraction of ≥50%.
    4. Fit for Intensive Therapy per Investigator opinion.

  • Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).

  • Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.

  • Known history of BCR-ABL mutation.

  • History of other active concurrent malignancies prior to study entry except:

    1. Basal cell skin cancer or localized squamous cell cancer of the skin
    2. Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
    3. Prostate or breast cancer receiving adjuvant hormonal therapy.
  • Active central nervous system (CNS) involvement by AML.

  • Clinical signs/symptoms of leukostasis or white blood cells (WBC) >25×10^9/L prior to start of ziftomenib/placebo. Note: Hydroxyurea and/or leukapheresis are permitted to meet this criterion.

  • Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.

  • Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.

  • Women who are pregnant or lactating.

Kura Oncology, Inc. logoKura Oncology
Contato central do estudo
Contato: Kura Medical Information, 844-KURAONC (844-587-2662), [email protected]
29 Locais do estudo em 1 países

Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, 85234, United States
Em recrutamento

California

University of California, San Diego, La Jolla, California, 92093, United States
Em recrutamento
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Em recrutamento
University of California, Irvine, Orange, California, 92868, United States
Em recrutamento

Colorado

Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States
Em recrutamento

Connecticut

Yale University School of Medicine, New Haven, Connecticut, 06510, United States
Em recrutamento

Florida

University of Miami, Miami, Florida, 33136, United States
Em recrutamento
Moffitt Cancer Center & Research Institute, Tampa, Florida, 33612, United States
Em recrutamento

Kentucky

University of Kentucky, Lexington, Kentucky, 40536, United States
Em recrutamento

Michigan

Wayne State University School of Medicine, Detroit, Michigan, 48201, United States
Em recrutamento

Minnesota

University of Minnesota, Minneapolis, Minnesota, 55455, United States
Em recrutamento

New Jersey

Rutgers Biomedical and Health Sciences, New Brunswick, New Jersey, 08903, United States
Em recrutamento

New Mexico

University of New Mexico, Albuquerque, New Mexico, 87131, United States
Em recrutamento

New York

Icahn School of Medicine at Mount Sinai, New York, New York, 10003, United States
Em recrutamento

North Carolina

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Em recrutamento
Duke University Medical Center, Durham, North Carolina, 27710, United States
Em recrutamento

Ohio

Ohio State University, Columbus, Ohio, 43210, United States
Em recrutamento

Oregon

Willamette Valley Cancer Institute, Eugene, Oregon, 97401, United States
Em recrutamento

Pennsylvania

University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Em recrutamento

Tennessee

Baptist Clinical Research Institute, Memphis, Tennessee, 38120, United States
Em recrutamento
Tennessee Oncology, Nashville, Tennessee, 37203, United States
Em recrutamento
TriStar Centennial Medical Center, Nashville, Tennessee, 37203, United States
Em recrutamento

Texas

Texas Oncology-Austin Midtown, Austin, Texas, 78705, United States
Em recrutamento
Texas Oncology-Presbyterian Cancer Center, Dallas, Texas, 75231, United States
Em recrutamento
University of Texas, Houston, Texas, 77030, United States
Em recrutamento
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, 78240, United States
Em recrutamento

Virginia

University of Virginia School of Medicine, Charlottesville, Virginia, 22903, United States
Em recrutamento
Virginia Cancer Specialists, Manassas, Virginia, 20110, United States
Em recrutamento

West Virginia

WVU Medicine Wheeling Hospital, Wheeling, West Virginia, 26003, United States
Em recrutamento