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Testando a adição de venetoclax ou gemtuzumab ozogamicina (GO) ao regime de tratamento usual (citarabina e daunorrubicina, "7+3") para o fator de ligação do núcleo leucemia mielóide aguda (CBF-AML) para melhorar a resposta (um estudo de tratamento da mielomatch)

3 de novembro de 2026 atualizado por: National Cancer Institute (NCI)

Estudo de Fase II da citarabina + daunorrubicina (7 + 3) + gemtuzumab ozogamicina vs. citarabina + daunorrubicina (7 + 3) + venetoclax para o tratamento de um fator de ligação do núcleo recém-diagnosticado: um subestrinho de mielóide do núcleo (CBF-AML) em adultos mais jovens: um subestim de mielóides de CBF (CBF):

This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVE:

I. Compare the rates of complete remission (CR) without measurable residual disease (CRMRD-) by multiparameter flow cytometry following induction therapy between the two treatment arms in each cohort separately.

SECONDARY OBJECTIVES:

I. To compare the rates of CR and composite complete remission (CRc) (CR+complete remission with incomplete hematologic recovery [CRi]+complete remission with partial hematologic recovery [CRh]) between the treatment arms.

II. To compare the overall survival (OS) between the treatment arms. III. To compare the event-free survival (EFS). IV. To compare the cumulative incidence of relapse (CIR). V. To compare the cumulative incidence of death (CID) between the treatment arms.

VI. To compare the rate of early death at 30 days and 60 days between the treatment arms.

VII. To assess the rate and frequency of adverse events between treatment arms. VIII. To evaluate mutant RAS and mutant KIT as predictive biomarkers for CRMRD- rate in CBF AML.

EXPLORATORY OBJECTIVE:

I. To compare MRD (and its clinical implication, e.g., relapse rates) between flow cytometry (FC) and next generation sequencing (NGS)-based (RUNX1::RUNX1T1 or CBFB::MYH11).

CORRELATIVE OBJECTIVES:

I. To evaluate the frequency and clinical impact of variant allele frequency (VAF) of KIT mutation, KIT mutations in different exons (e.g., exon 8 or 17), CD33 expression, additional (secondary) mutations and cytogenetic abnormalities.

II. To evaluate the differences in clinical and molecular outcomes in patients with RUNX1::RUNX1T1 mutated versus CBFB::MYH11 mutated CBF AML.

OUTLINE: Patients are randomized to 1 of 2 regimens.

REGIMEN 1: Patients receive gemtuzumab ozogamicin intravenously (IV) on day 1, 2 or 3 and on day 4, 5, or 6 (NOTE: two doses must be at least 3 days apart), as well as cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or multigated acquisition (MUGA) scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study.

REGIMEN 2: Patients receive venetoclax orally (PO) once daily (QD) on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration, as well as blood sample collection throughout the study.

After completion of study treatment, patients are followed up at relapse and every 3 months for 2 years, then every 6 months until 5 years.

Tipo de estudo

Intervencional

Inscrição (Estimado)

162

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Recrutamento
        • University of Alabama at Birmingham Cancer Center
        • Investigador principal:
          • Razan Mohty
        • Contato:
    • California
      • La Jolla, California, Estados Unidos, 92093
        • Recrutamento
        • UC San Diego Moores Cancer Center
        • Contato:
        • Investigador principal:
          • Tiffany N. Tanaka
    • Florida
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Recrutamento
        • Memorial Hospital West
        • Contato:
          • Site Public Contact
          • Número de telefone: 954-265-4325
        • Investigador principal:
          • Yehuda E. Deutsch
    • Idaho
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Recrutamento
        • Kootenai Health - Coeur d'Alene
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Post Falls, Idaho, Estados Unidos, 83854
        • Recrutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Sandpoint, Idaho, Estados Unidos, 83864
        • Recrutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Recrutamento
        • University of Chicago Comprehensive Cancer Center
        • Contato:
        • Investigador principal:
          • Olatoyosi M. Odenike
      • Chicago, Illinois, Estados Unidos, 60611
        • Recrutamento
        • Northwestern University
        • Contato:
        • Investigador principal:
          • Yuchen Liu
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • University of Illinois
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-355-3046
        • Investigador principal:
          • Noah Birch
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • Rush MD Anderson Cancer Center
        • Contato:
        • Investigador principal:
          • Melissa L. Larson
      • New Lenox, Illinois, Estados Unidos, 60451
        • Recrutamento
        • UC Comprehensive Cancer Center at Silver Cross
        • Contato:
        • Investigador principal:
          • Olatoyosi M. Odenike
      • Orland Park, Illinois, Estados Unidos, 60462
        • Recrutamento
        • University of Chicago Medicine-Orland Park
        • Contato:
        • Investigador principal:
          • Olatoyosi M. Odenike
    • Indiana
      • Crown Point, Indiana, Estados Unidos, 46307
        • Recrutamento
        • UChicago Medicine Northwest Indiana
        • Investigador principal:
          • Olatoyosi M. Odenike
        • Contato:
    • Kansas
      • Fairway, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Clinical Research Center
        • Contato:
        • Investigador principal:
          • Jesus Gonzalez Lugo
      • Kansas City, Kansas, Estados Unidos, 66160
        • Recrutamento
        • University of Kansas Cancer Center
        • Contato:
        • Investigador principal:
          • Jesus Gonzalez Lugo
      • Overland Park, Kansas, Estados Unidos, 66211
        • Recrutamento
        • University of Kansas Hospital-Indian Creek Campus
        • Contato:
        • Investigador principal:
          • Jesus Gonzalez Lugo
      • Westwood, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Contato:
        • Investigador principal:
          • Jesus Gonzalez Lugo
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • Recrutamento
        • University of Kentucky/Markey Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 859-257-3379
        • Investigador principal:
          • Fevzi Yalniz
      • Louisville, Kentucky, Estados Unidos, 40202
        • Recrutamento
        • The James Graham Brown Cancer Center at University of Louisville
        • Investigador principal:
          • Mohamed M. Hegazi
        • Contato:
          • Site Public Contact
          • Número de telefone: 502-562-3429
      • Louisville, Kentucky, Estados Unidos, 40245
        • Recrutamento
        • UofL Health Medical Center Northeast
        • Investigador principal:
          • Mohamed M. Hegazi
        • Contato:
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Recrutamento
        • Our Lady of the Lake Physician Group
        • Contato:
        • Investigador principal:
          • Harry G. Sequeira Gross
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Recrutamento
        • Dana-Farber Cancer Institute
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-442-3324
        • Investigador principal:
          • Eric S. Winer
      • Boston, Massachusetts, Estados Unidos, 02111
    • Michigan
      • Brighton, Michigan, Estados Unidos, 48114
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Canton, Michigan, Estados Unidos, 48188
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Estados Unidos, 48118
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Livonia, Michigan, Estados Unidos, 48154
        • Recrutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Pontiac, Michigan, Estados Unidos, 48341
        • Recrutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
    • Mississippi
      • Columbus, Mississippi, Estados Unidos, 39705
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Investigador principal:
          • Salil Goorha
        • Contato:
      • Grenada, Mississippi, Estados Unidos, 38901
        • Recrutamento
        • Baptist Cancer Center-Grenada
        • Investigador principal:
          • Salil Goorha
        • Contato:
      • New Albany, Mississippi, Estados Unidos, 38652
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Investigador principal:
          • Salil Goorha
        • Contato:
      • Oxford, Mississippi, Estados Unidos, 38655
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Investigador principal:
          • Salil Goorha
        • Contato:
      • Southhaven, Mississippi, Estados Unidos, 38671
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Investigador principal:
          • Salil Goorha
        • Contato:
    • Missouri
      • City of Saint Peters, Missouri, Estados Unidos, 63376
        • Recrutamento
        • Siteman Cancer Center at Saint Peters Hospital
        • Contato:
        • Investigador principal:
          • Ramzi Abboud
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Recrutamento
        • Siteman Cancer Center at West County Hospital
        • Contato:
        • Investigador principal:
          • Ramzi Abboud
      • St Louis, Missouri, Estados Unidos, 63110
        • Recrutamento
        • Washington University School of Medicine
        • Contato:
        • Investigador principal:
          • Ramzi Abboud
      • St Louis, Missouri, Estados Unidos, 63129
        • Recrutamento
        • Siteman Cancer Center-South County
        • Contato:
        • Investigador principal:
          • Ramzi Abboud
      • St Louis, Missouri, Estados Unidos, 63136
        • Recrutamento
        • Siteman Cancer Center at Christian Hospital
        • Contato:
        • Investigador principal:
          • Ramzi Abboud
    • Montana
      • Anaconda, Montana, Estados Unidos, 59711
        • Recrutamento
        • Community Hospital of Anaconda
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Billings, Montana, Estados Unidos, 59101
        • Recrutamento
        • Billings Clinic Cancer Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Bozeman, Montana, Estados Unidos, 59715
        • Recrutamento
        • Bozeman Health Deaconess Hospital
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Great Falls, Montana, Estados Unidos, 59405
        • Recrutamento
        • Benefis Sletten Cancer Institute
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Kalispell, Montana, Estados Unidos, 59901
        • Recrutamento
        • Logan Health Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Missoula, Montana, Estados Unidos, 59804
        • Recrutamento
        • Community Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Recrutamento
        • Nebraska Medicine-Bellevue
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
        • Investigador principal:
          • Michael Haddadin
      • Omaha, Nebraska, Estados Unidos, 68198
        • Recrutamento
        • University of Nebraska Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
        • Investigador principal:
          • Michael Haddadin
      • Omaha, Nebraska, Estados Unidos, 68118
        • Recrutamento
        • Nebraska Medicine-Village Pointe
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-5600
        • Investigador principal:
          • Michael Haddadin
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Recrutamento
        • University of New Mexico Cancer Center
        • Contato:
        • Investigador principal:
          • Charles Foucar
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Recrutamento
        • Roswell Park Cancer Institute
        • Investigador principal:
          • Eunice S. Wang
        • Contato:
      • Rochester, New York, Estados Unidos, 14642
        • Recrutamento
        • University of Rochester
        • Contato:
          • Site Public Contact
          • Número de telefone: 585-275-5830
        • Investigador principal:
          • Bassil Botros
      • Syracuse, New York, Estados Unidos, 13210
        • Recrutamento
        • State University of New York Upstate Medical University
        • Investigador principal:
          • Teresa C. Gentile
        • Contato:
          • Site Public Contact
          • Número de telefone: 315-464-5476
      • The Bronx, New York, Estados Unidos, 10467
        • Recrutamento
        • Montefiore Medical Center - Moses Campus
        • Investigador principal:
          • Ioannis Mantzaris
        • Contato:
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Recrutamento
        • Duke University Medical Center
        • Investigador principal:
          • Harry P. Erba
        • Contato:
          • Site Public Contact
          • Número de telefone: 888-275-3853
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • Ohio State University Comprehensive Cancer Center
        • Investigador principal:
          • Alice S. Mims
        • Contato:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma Health Sciences Center
        • Contato:
        • Investigador principal:
          • Zimu Gong
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Recrutamento
        • Geisinger Medical Center
        • Investigador principal:
          • Joseph J. Vadakara
        • Contato:
      • Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
        • Recrutamento
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contato:
        • Investigador principal:
          • Joseph J. Vadakara
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Recrutamento
        • Rhode Island Hospital
        • Investigador principal:
          • John L. Reagan
        • Contato:
          • Site Public Contact
          • Número de telefone: 401-444-1488
    • South Carolina
      • Boiling Springs, South Carolina, Estados Unidos, 29316
        • Recrutamento
        • Prisma Health Cancer Institute - Spartanburg
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Easley, South Carolina, Estados Unidos, 29640
        • Recrutamento
        • Prisma Health Cancer Institute - Easley
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Recrutamento
        • Prisma Health Cancer Institute - Faris
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Recrutamento
        • Prisma Health Cancer Institute - Butternut
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29615
        • Recrutamento
        • Prisma Health Cancer Institute - Eastside
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Greer, South Carolina, Estados Unidos, 29650
        • Recrutamento
        • Prisma Health Cancer Institute - Greer
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
      • Seneca, South Carolina, Estados Unidos, 29672
        • Recrutamento
        • Prisma Health Cancer Institute - Seneca
        • Investigador principal:
          • Suzanne R. Fanning
        • Contato:
    • Tennessee
      • Collierville, Tennessee, Estados Unidos, 38017
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Investigador principal:
          • Salil Goorha
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38120
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Investigador principal:
          • Salil Goorha
        • Contato:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Recrutamento
        • Huntsman Cancer Institute/University of Utah
        • Contato:
        • Investigador principal:
          • Paul J. Shami
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Recrutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigador principal:
          • Keri R. Maher
        • Contato:
    • Washington
      • Edmonds, Washington, Estados Unidos, 98026
        • Recrutamento
        • Swedish Cancer Institute-Edmonds
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Issaquah, Washington, Estados Unidos, 98029
        • Recrutamento
        • Swedish Cancer Institute-Issaquah
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Seattle, Washington, Estados Unidos, 98122
        • Recrutamento
        • Swedish Medical Center-First Hill
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
    • Wisconsin
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Recrutamento
        • Gundersen Lutheran Medical Center
        • Contato:
        • Investigador principal:
          • Michael O. Ojelabi
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Recrutamento
        • Froedtert Menomonee Falls Hospital
        • Investigador principal:
          • Ehab L. Atallah
        • Contato:
          • Site Public Contact
          • Número de telefone: 262-257-5100
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Recrutamento
        • Medical College of Wisconsin
        • Investigador principal:
          • Ehab L. Atallah
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-3666
      • New Berlin, Wisconsin, Estados Unidos, 53151
        • Recrutamento
        • Froedtert and MCW Moorland Reserve Health Center
        • Investigador principal:
          • Ehab L. Atallah
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-0505
      • Oak Creek, Wisconsin, Estados Unidos, 53154
        • Recrutamento
        • Drexel Town Square Health Center
        • Investigador principal:
          • Ehab L. Atallah
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-0505
      • West Bend, Wisconsin, Estados Unidos, 53095
        • Recrutamento
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Investigador principal:
          • Ehab L. Atallah
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-0505
  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Recrutamento
        • Centro Comprensivo de Cancer de UPR
        • Investigador principal:
          • Luis J. Santos Reyes
        • Contato:
      • San Juan, Porto Rico, 00936
        • Recrutamento
        • San Juan City Hospital
        • Investigador principal:
          • Luis J. Santos Reyes
        • Contato:
          • Site Public Contact
          • Número de telefone: 787-763-1296

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 59 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team

  • GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS)

    • Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed.
    • Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility

  • GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed

  • Diagnosis of AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study)

  • Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed.

  • No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted

  • Age 18-59 years

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN)

  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)

  • Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m^2

  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease

  • Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better

  • No known medical condition causing an inability to swallow oral formulations of agents

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Regimen 1 (gemtuzumab ozogamicin 7+3)

Patients receive gemtuzumab ozogamicin IV on day 1, 2 or 3 and on day 4, 5, or 6 (NOTE: two doses must be at least 3 days apart), as well as cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study.
Medicamento: Cytarabine

Given IV

Outros nomes:
  • .beta.-Citosina arabinósido
  • 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona
  • 1-.beta.-D-Arabinofuranosilcitosina
  • 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona
  • 1-Beta-D-arabinofuranosilcitosina
  • 1.beta.-D-Arabinofuranosilcitosina
  • 2(1H)-Pirimidinona, 4-Amino-1-beta-D-arabinofuranosil-
  • 2(1H)-Pirimidinona, 4-amino-1.beta.-D-arabinofuranosil-
  • Alexan
  • Ara-C
  • Célula ARA
  • Árabe
  • Arabinofuranosilcitosina
  • Arabinosilcitosina
  • Aracitidina
  • Aracitina
  • Beta-citosina arabinosídeo
  • CHX-3311
  • Citarabina
  • Citarbel
  • Cytosar
  • Citosina Arabinosídeo
  • Citosina-.beta.-arabinósido
  • Citosina-beta-arabinósido
  • Erpalfa
  • Starasid
  • Tarabina PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Medicamento: Gemtuzumab Ozogamicin

Given IV

Outros nomes:
  • Mylotarg
  • Anticorpo monoclonal anti-CD33 humanizado conjugado com caliqueamicina
  • CDP-771
  • CMA-676
  • gemtuzumabe
  • hP67.6-Caliqueamicina
  • WAY-CMA-676
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicamento: Daunorubicin Hydrochloride

Given IV

Outros nomes:
  • Cerubidin
  • Cerubidina
  • Cloridrato de Daunorubicina
  • Daunoblastina
  • Cloridrato de Daunomicina
  • Daunomicina, cloridrato
  • Daunorrubicina.HCl
  • Cloridrato de Daunorubicini
  • FI-6339
  • Ondena
  • RP-13057
  • Cloridrato de Rubidomicina
  • Rubilem
Procedimento: Multigated Acquisition Scan

Undergo MUGA scan

Outros nomes:
  • Varredura de sangue
  • Angiografia com Radionuclídeos de Equilíbrio
  • Imagem de pool de sangue fechado
  • MUGA
  • Ventriculografia com radionuclídeo
  • RNVG
  • Digitalização SIMA
  • Varredura de Aquisição Multigatada Sincronizada
  • Varredura MUGA
  • Varredura de Aquisição Multi-Gated
  • Varredura de ventriculograma com radionuclídeo
  • Varredura de pool de coração fechado
  • Varredura RNV
Procedimento: Echocardiography Test

Undergo echocardiography

Outros nomes:
  • Ecocardiografia
  • CE
Experimental: Regimen 2 (Venetoclax, 7+3)

Patients receive venetoclax orally (PO) once daily (QD) on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration, as well as blood sample collection throughout the study.
Medicamento: Cytarabine

Given IV

Outros nomes:
  • .beta.-Citosina arabinósido
  • 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona
  • 1-.beta.-D-Arabinofuranosilcitosina
  • 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona
  • 1-Beta-D-arabinofuranosilcitosina
  • 1.beta.-D-Arabinofuranosilcitosina
  • 2(1H)-Pirimidinona, 4-Amino-1-beta-D-arabinofuranosil-
  • 2(1H)-Pirimidinona, 4-amino-1.beta.-D-arabinofuranosil-
  • Alexan
  • Ara-C
  • Célula ARA
  • Árabe
  • Arabinofuranosilcitosina
  • Arabinosilcitosina
  • Aracitidina
  • Aracitina
  • Beta-citosina arabinosídeo
  • CHX-3311
  • Citarabina
  • Citarbel
  • Cytosar
  • Citosina Arabinosídeo
  • Citosina-.beta.-arabinósido
  • Citosina-beta-arabinósido
  • Erpalfa
  • Starasid
  • Tarabina PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicamento: Daunorubicin Hydrochloride

Given IV

Outros nomes:
  • Cerubidin
  • Cerubidina
  • Cloridrato de Daunorubicina
  • Daunoblastina
  • Cloridrato de Daunomicina
  • Daunomicina, cloridrato
  • Daunorrubicina.HCl
  • Cloridrato de Daunorubicini
  • FI-6339
  • Ondena
  • RP-13057
  • Cloridrato de Rubidomicina
  • Rubilem
Procedimento: Multigated Acquisition Scan

Undergo MUGA scan

Outros nomes:
  • Varredura de sangue
  • Angiografia com Radionuclídeos de Equilíbrio
  • Imagem de pool de sangue fechado
  • MUGA
  • Ventriculografia com radionuclídeo
  • RNVG
  • Digitalização SIMA
  • Varredura de Aquisição Multigatada Sincronizada
  • Varredura MUGA
  • Varredura de Aquisição Multi-Gated
  • Varredura de ventriculograma com radionuclídeo
  • Varredura de pool de coração fechado
  • Varredura RNV
Medicamento: Venetoclax

Given PO

Outros nomes:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Procedimento: Echocardiography Test

Undergo echocardiography

Outros nomes:
  • Ecocardiografia
  • CE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Complete remission without measurable residual disease (CRMRD-)
Prazo: At end of induction (Up to 28 days)

MRD will be evaluated by Molecular Diagnostics Network flow cytometry and will be defined at a threshold of ≤ 10^-3.
At end of induction (Up to 28 days)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of complete remission (CR)
Prazo: At the end of treatment (Up to 28 days)

Defined as the number of evaluable patients achieving a response of CR per European Leukemia Network (ELN) 2022 criteria at the end of treatment divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for CR rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
At the end of treatment (Up to 28 days)
Rate of composite CR
Prazo: At the end of treatment (Up to 28 days)

Defined as the number of evaluable patients achieving a response of CR or complete remission with incomplete hematologic recovery (CRi) or complete remission with partial hematologic recovery (CRh) per ELN 2022 criteria at the end of treatment divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for CR rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
At the end of treatment (Up to 28 days)
Overall survival (OS)
Prazo: From registration until death due to any cause, up to 5 years

The distribution of OS will be estimated using method of Kaplan-Meier. The median OS and 95% confidence interval will be reported.
From registration until death due to any cause, up to 5 years
Event free survival (EVS)
Prazo: From randomization to induction failure, hematologic relapse from CR/CRh/CRi or death from any cause, whichever occurs first, up to 5 years

Induction failure is defined as not achieving either CR, CRh or CRi by after induction therapy. The distribution of EFS will be estimated using method of Kaplan-Meier, and compared using log-rank tests. The median EFS and the corresponding 95% confidence interval will be reported.
From randomization to induction failure, hematologic relapse from CR/CRh/CRi or death from any cause, whichever occurs first, up to 5 years
Cumulative incidence of relapse (CIR)
Prazo: From the date of achievement of a remission until the date of hematologic relapse, up to 5 years

The distribution of CIR will be estimated using Fine-Gray model and reported via hazard ratios and 95% confidence interval with p values.
From the date of achievement of a remission until the date of hematologic relapse, up to 5 years
Cumulative incidence of death (CID)
Prazo: From the date of achievement of a remission to death without prior relapse, up to 5 years

The distribution of CID will be estimated using Fine-Gray model and reported via hazard ratios and 95% confidence interval with p values.
From the date of achievement of a remission to death without prior relapse, up to 5 years
Rate of early death at 30 days (ED-30)
Prazo: At 30 days

ED-30 is defined as the total number of patients who died on or before day 30 from randomization divided by the total number of evaluable patients. Rate of early death at day 30 will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for ED-30 rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
At 30 days
Rate of early death at 60 days (ED-60)
Prazo: At 60 days

ED-60 is defined as the total number of patients who died on or before day 60 from randomization divided by the total number of evaluable patients. Rate of early death at day 60 will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for ED-60 rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
At 60 days
Incidence of adverse events
Prazo: Up to 5 years

As per national Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm and will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.
Up to 5 years
Evaluate mutant RAS and mutant KIT as predictive biomarkers for CRMRD- rate
Prazo: Up to 5 years

In cohort 1, subgroup analysis will be conducted to evaluate the treatment effect among RAS mutated patients using Kaplan Meier methods and log-rank tests; similar subgroup analysis will be done among KIT mutated patients.
Up to 5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Celalettin Ustun, Alliance for Clinical Trials in Oncology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de setembro de 2026

Conclusão Primária (Estimado)

25 de novembro de 2027

Conclusão do estudo (Estimado)

25 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de abril de 2025

Primeira postagem (Real)

9 de abril de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2025-02426
  • U10CA180821 (Concessão/Contrato do NIH dos EUA)
  • NCI-2025-02426 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • MM1YA-A04 (Outro identificador: CTEP)
  • MM1YA-A04 (Outro identificador: Alliance for Clinical Trials in Oncology)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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