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Comparação de novos tratamentos para pessoas com leucemia mieloide aguda recém-diagnosticada que apresenta alteração no gene IDH2 (um ensaio de tratamento MyeloMATCH)

24 de outubro de 2026 atualizado por: National Cancer Institute (NCI)

Um ensaio randomizado de fase II de decitabina oral, cedazuridina e Venetoclax em comparação com decitabina oral e cedazuridina, Venetoclax e enasidenibe para idosos recém-diagnosticados com leucemia mieloide aguda mutante IDH2: um ensaio de tratamento MyeloMATCH

This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML.

ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. 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. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVES:

I. To evaluate the safety of decitabine and cedazuridine (ASTX727) + venetoclax + enasidenib (Arm 2) before initiating randomization.

II. To compare the rate of measurable residual disease (MRD) negative complete remission with or without partial hematologic recovery (complete remission [CR] or complete remission with partial hematologic recovery [CRh]) based on multiparameter flow cytometry (MFC) after two cycles of treatment in older adults (or unfit adults age 18 or older) with IDH2 mutated acute myeloid leukemia (AML) who receive ASTX727, venetoclax, and enasidenib versus ASTX727 and venetoclax alone.

III. If the rate of measurable residual disease (MRD) negative CR+CRh is significantly higher on the ASTX727, venetoclax, and enasidenib arm compared to the ASTX727 and venetoclax arm, to hierarchically evaluate whether the measurable residual disease (MRD) negative CR rate is different between the randomized arms.

SECONDARY OBJECTIVES:

I. To estimate the rate of composite remission (CR + complete remission with incomplete count recovery [CRi] + complete remission with partial hematologic recovery [CRh]), relapse-free survival (RFS), event-free survival (EFS), duration of response (DOR), and overall survival (OS) of participants by treatment arm.

II. To estimate IDH2 mutated variant allele frequency, flow cytometry MRD, and molecular MRD after two cycles of therapy in participants' bone marrow aspirates and blood by treatment arm.

III. To estimate remission rates (CR with and without MRD [MFC and molecular MRD], CRh and CRi), and to estimate the rates of hematologic improvement by treatment arm.

IV. To estimate the frequency and severity of adverse events by treatment arm. V. To evaluate the association between MFC and molecular MRD after two cycles of protocol treatment with the outcomes RFS and OS (landmarked by date of MRD measurement) by treatment arm.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ASTX727 orally (PO) once daily (QD) on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

All patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months until 5 years after registration or death.

Tipo de estudo

Intervencional

Inscrição (Estimado)

93

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
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
        • Recrutamento
        • Banner University Medical Center - Tucson
        • Investigador principal:
          • Sharad Khurana
        • Contato:
      • Tucson, Arizona, Estados Unidos, 85719
        • Recrutamento
        • University of Arizona Cancer Center-North Campus
        • Investigador principal:
          • Sharad Khurana
        • Contato:
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Recrutamento
        • University of Arkansas for Medical Sciences
        • Contato:
          • Site Public Contact
          • Número de telefone: 501-686-8274
        • Investigador principal:
          • Ankur Varma
    • California
      • Berkeley, California, Estados Unidos, 94704
        • Ativo, não recrutando
        • Alta Bates Summit Medical Center-Herrick Campus
      • San Francisco, California, Estados Unidos, 94143
        • Recrutamento
        • UCSF Medical Center-Parnassus
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-3222
        • Investigador principal:
          • Timothy Ferng
      • San Mateo, California, Estados Unidos, 94401
        • Ativo, não recrutando
        • Mills Health Center
    • Florida
      • Hollywood, Florida, Estados Unidos, 33021
        • Suspenso
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Miami, Florida, Estados Unidos, 33176
        • Recrutamento
        • Miami Cancer Institute
        • Investigador principal:
          • Firas El Chaer
        • Contato:
          • Site Public Contact
          • Número de telefone: 786-596-2000
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Recrutamento
        • Memorial Hospital West
        • Contato:
          • Site Public Contact
          • Número de telefone: 954-265-4325
        • Investigador principal:
          • Stanislav Ivanov
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Recrutamento
        • Augusta University Medical Center
        • Investigador principal:
          • Vamsi Kota
        • Contato:
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Recrutamento
        • Saint Luke's Cancer Institute - Boise
        • Contato:
        • Investigador principal:
          • Charles W. Drescher
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Recrutamento
        • Kootenai Health - Coeur d'Alene
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Fruitland, Idaho, Estados Unidos, 83619
        • Recrutamento
        • Saint Luke's Cancer Institute - Fruitland
        • Contato:
        • Investigador principal:
          • Charles W. Drescher
      • Meridian, Idaho, Estados Unidos, 83642
        • Recrutamento
        • Saint Luke's Cancer Institute - Meridian
        • Contato:
        • Investigador principal:
          • Charles W. Drescher
      • Nampa, Idaho, Estados Unidos, 83687
        • Recrutamento
        • Saint Luke's Cancer Institute - Nampa
        • Contato:
        • Investigador principal:
          • Charles W. Drescher
      • Nampa, Idaho, Estados Unidos, 83687
        • Recrutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • 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:
          • Himachandana Atluri
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • University of Illinois
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-355-3046
        • Investigador principal:
          • Noah Birch
      • DeKalb, Illinois, Estados Unidos, 60115
        • Recrutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contato:
        • Investigador principal:
          • Himachandana Atluri
      • Evanston, Illinois, Estados Unidos, 60201
        • Recrutamento
        • NorthShore University HealthSystem-Evanston Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
        • Investigador principal:
          • David L. Grinblatt
      • Geneva, Illinois, Estados Unidos, 60134
        • Recrutamento
        • Northwestern Medicine Cancer Center Delnor
        • Contato:
        • Investigador principal:
          • Himachandana Atluri
      • Glenview, Illinois, Estados Unidos, 60026
        • Recrutamento
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
        • Investigador principal:
          • David L. Grinblatt
      • Glenview, Illinois, Estados Unidos, 60026
        • Recrutamento
        • Northwestern Medicine Glenview Outpatient Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-695-1102
        • Investigador principal:
          • Himachandana Atluri
      • Grayslake, Illinois, Estados Unidos, 60030
        • Recrutamento
        • Northwestern Medicine Grayslake Outpatient Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-695-1102
        • Investigador principal:
          • Himachandana Atluri
      • Highland Park, Illinois, Estados Unidos, 60035
        • Recrutamento
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
        • Investigador principal:
          • David L. Grinblatt
      • Hines, Illinois, Estados Unidos, 60141
        • Recrutamento
        • Edward Hines Jr VA Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 708-202-8387
        • Investigador principal:
          • Jorgena Kosti-Schwartz
      • Lake Forest, Illinois, Estados Unidos, 60045
        • Recrutamento
        • Northwestern Medicine Lake Forest Hospital
        • Contato:
        • Investigador principal:
          • Himachandana Atluri
      • Maywood, Illinois, Estados Unidos, 60153
        • Recrutamento
        • Loyola University Medical Center
        • Investigador principal:
          • Stephanie B. Tsai
        • Contato:
          • Site Public Contact
          • Número de telefone: 708-226-4357
      • 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
      • Orland Park, Illinois, Estados Unidos, 60462
      • Warrenville, Illinois, Estados Unidos, 60555
        • Recrutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Contato:
        • Investigador principal:
          • Himachandana Atluri
    • 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
        • Investigador principal:
          • Kenneth Byrd
        • Contato:
      • Kansas City, Kansas, Estados Unidos, 66160
        • Recrutamento
        • University of Kansas Cancer Center
        • Investigador principal:
          • Kenneth Byrd
        • Contato:
      • Westwood, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Investigador principal:
          • Kenneth Byrd
        • Contato:
    • Kentucky
      • 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, 70805
        • Recrutamento
        • LSU Health Baton Rouge-North Clinic
        • Contato:
        • Investigador principal:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Recrutamento
        • Our Lady of The Lake
        • Contato:
          • Site Public Contact
          • Número de telefone: 225-765-7659
        • Investigador principal:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Estados Unidos, 70808
        • Recrutamento
        • Our Lady of the Lake Physician Group
        • Contato:
        • Investigador principal:
          • Harry G. Sequeira Gross
    • Maine
      • Brunswick, Maine, Estados Unidos, 04011
        • Recrutamento
        • Mid Coast Hospital
        • Contato:
        • Investigador principal:
          • Pamela Egan
      • Brunswick, Maine, Estados Unidos, 04011
        • Recrutamento
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Investigador principal:
          • Pamela Egan
        • Contato:
      • Portland, Maine, Estados Unidos, 04102
        • Recrutamento
        • MaineHealth Maine Medical Center - Portland
        • Investigador principal:
          • Pamela Egan
        • Contato:
      • Scarborough, Maine, Estados Unidos, 04074
        • Recrutamento
        • MaineHealth Maine Medical Center- Scarborough
        • Investigador principal:
          • Pamela Egan
        • Contato:
      • South Portland, Maine, Estados Unidos, 04106
        • Recrutamento
        • MaineHealth Cancer Care and IV Therapy - South Portland
        • Investigador principal:
          • Pamela Egan
        • Contato:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
    • Michigan
      • Brighton, Michigan, Estados Unidos, 48114
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Canton, Michigan, Estados Unidos, 48188
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Chelsea, Michigan, Estados Unidos, 48118
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Clinton Township, Michigan, Estados Unidos, 48038
        • Ativo, não recrutando
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, Estados Unidos, 48202
        • Ativo, não recrutando
        • Henry Ford Hospital
      • Escanaba, Michigan, Estados Unidos, 49829
        • Recrutamento
        • OSF Saint Francis Hospital and Medical Group
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Genesys Hurley Cancer Institute
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Elie G. Dib
      • Flint, Michigan, Estados Unidos, 48503
        • Suspenso
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Cancer Hematology Centers - Flint
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Elie G. Dib
      • Jackson, Michigan, Estados Unidos, 49201
        • Ativo, não recrutando
        • Allegiance Health
      • Livonia, Michigan, Estados Unidos, 48154
        • Recrutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Novi, Michigan, Estados Unidos, 48377
        • Ativo, não recrutando
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, Estados Unidos, 48341
        • Recrutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Ativo, não recrutando
        • Henry Ford West Bloomfield Hospital
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contato:
        • Investigador principal:
          • Elie G. Dib
    • Minnesota
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Recrutamento
        • Mercy Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Deer River, Minnesota, Estados Unidos, 56636
        • Recrutamento
        • Essentia Health - Deer River Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Duluth, Minnesota, Estados Unidos, 55805
        • Recrutamento
        • Essentia Health Cancer Center
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Edina, Minnesota, Estados Unidos, 55435
        • Recrutamento
        • Fairview Southdale Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Edina, Minnesota, Estados Unidos, 55435
        • Recrutamento
        • Minnesota Oncology - Edina
        • Contato:
        • Investigador principal:
          • David M. King
      • Hibbing, Minnesota, Estados Unidos, 55746
        • Recrutamento
        • Essentia Health Hibbing Clinic
        • Investigador principal:
          • Bret E. Friday
        • Contato:
          • Site Public Contact
          • Número de telefone: 218-786-3308
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Recrutamento
        • Abbott-Northwestern Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Recrutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Recrutamento
        • Regions Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • Recrutamento
        • United Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Sandstone, Minnesota, Estados Unidos, 55072
        • Recrutamento
        • Essentia Health Sandstone
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Virginia, Minnesota, Estados Unidos, 55792
        • Recrutamento
        • Essentia Health Virginia Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
    • 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:
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Recrutamento
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contato:
        • Investigador principal:
          • Patrick W. Mellors
    • New Jersey
      • Basking Ridge, New Jersey, Estados Unidos, 07920
        • Recrutamento
        • Memorial Sloan Kettering Basking Ridge
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • Livingston, New Jersey, Estados Unidos, 07039
        • Recrutamento
        • Cooperman Barnabas Medical Center
        • Investigador principal:
          • Neil D. Palmisiano
        • Contato:
          • Site Public Contact
          • Número de telefone: 973-322-5200
      • Long Branch, New Jersey, Estados Unidos, 07740
        • Recrutamento
        • Monmouth Medical Center
        • Investigador principal:
          • Neil D. Palmisiano
        • Contato:
      • Middletown, New Jersey, Estados Unidos, 07748
        • Recrutamento
        • Memorial Sloan Kettering Monmouth
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • Montvale, New Jersey, Estados Unidos, 07645
        • Recrutamento
        • Memorial Sloan Kettering Bergen
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Recrutamento
        • Rutgers Cancer Institute of New Jersey
        • Investigador principal:
          • Neil D. Palmisiano
        • Contato:
          • Site Public Contact
          • Número de telefone: 732-235-7356
      • Toms River, New Jersey, Estados Unidos, 08755
        • Recrutamento
        • Community Medical Center
        • Investigador principal:
          • Neil D. Palmisiano
        • Contato:
    • 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:
      • Commack, New York, Estados Unidos, 11725
        • Recrutamento
        • Memorial Sloan Kettering Commack
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • Harrison, New York, Estados Unidos, 10604
        • Recrutamento
        • Memorial Sloan Kettering Westchester
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • New York, New York, Estados Unidos, 10065
        • Recrutamento
        • Memorial Sloan Kettering Cancer Center
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
      • Rochester, New York, Estados Unidos, 14642
        • Recrutamento
        • University of Rochester
        • Contato:
          • Site Public Contact
          • Número de telefone: 585-275-5830
        • Investigador principal:
          • Eric J. Huselton
      • Stony Brook, New York, Estados Unidos, 11794
        • Recrutamento
        • Stony Brook University Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-862-2215
        • Investigador principal:
          • Suhu Liu
      • 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
      • Uniondale, New York, Estados Unidos, 11553
        • Recrutamento
        • Memorial Sloan Kettering Nassau
        • Investigador principal:
          • Xin Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-639-7592
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Recrutamento
        • Carolinas Medical Center/Levine Cancer Institute
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-804-9376
        • Investigador principal:
          • Brittany K. Ragon
      • 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
      • Greenville, North Carolina, Estados Unidos, 27834
        • Recrutamento
        • East Carolina University
        • Investigador principal:
          • Darla K. Liles
        • Contato:
          • Site Public Contact
          • Número de telefone: 252-744-1015
          • E-mail: eubankss@ecu.edu
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Recrutamento
        • Wake Forest University Health Sciences
        • Investigador principal:
          • Matthew J. Wieduwilt
        • Contato:
          • Site Public Contact
          • Número de telefone: 336-713-6771
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma Health Sciences Center
        • Contato:
        • Investigador principal:
          • Manu Pandey
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Suspenso
        • Oregon Health and Science University
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Recrutamento
        • Geisinger Medical Center
        • Investigador principal:
          • Joseph J. Vadakara
        • Contato:
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Recrutamento
        • Thomas Jefferson University Hospital
        • Investigador principal:
          • Lindsay Wilde
        • Contato:
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • Recrutamento
        • UPMC Hillman Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 412-647-8073
        • Investigador principal:
          • Annie P. Im
      • 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
      • Knoxville, Tennessee, Estados Unidos, 37920
        • Suspenso
        • University of Tennessee - Knoxville
    • 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:
          • Charles W. Drescher
        • Contato:
      • Issaquah, Washington, Estados Unidos, 98029
        • Recrutamento
        • Swedish Cancer Institute-Issaquah
        • Investigador principal:
          • Charles W. Drescher
        • Contato:
      • Seattle, Washington, Estados Unidos, 98122
        • Recrutamento
        • Swedish Medical Center-First Hill
        • Investigador principal:
          • Charles W. Drescher
        • Contato:
    • Wisconsin
      • Ashland, Wisconsin, Estados Unidos, 54806
        • Recrutamento
        • Duluth Clinic Ashland
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Green Bay, Wisconsin, Estados Unidos, 54301
        • Recrutamento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Recrutamento
        • Gundersen Lutheran Medical Center
        • Contato:
        • Investigador principal:
          • David E. Marinier
      • Madison, Wisconsin, Estados Unidos, 53705
        • Recrutamento
        • William S Middleton VA Medical Center
        • Investigador principal:
          • Christopher D. Fletcher
        • Contato:
          • Site Public Contact
          • Número de telefone: 17007 608-256-1901
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Recrutamento
        • Medical College of Wisconsin
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-3666
        • Investigador principal:
          • Guru Subramanian Guru Murthy
      • Oconto Falls, Wisconsin, Estados Unidos, 54154
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Recrutamento
        • Sheboygan Physicians Group
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Stevens Point, Wisconsin, Estados Unidos, 54482
      • Sturgeon Bay, Wisconsin, Estados Unidos, 54235-1495
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigador principal:
          • Matthew L. Ryan
        • Contato:
      • Weston, Wisconsin, Estados Unidos, 54476
  • 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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study

    • Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH

  • Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral blood, or with an AML defining genetic abnormality as described by the World Health Organization (WHO) classification of AML, excluding acute promyelocytic leukemia (APL) with PML-RARA

  • Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy

  • Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, luspatercept, immunosuppressive therapy, intrathecal chemotherapy, cytarabine (up to 1 g/m^2 for the purpose of cytoreduction for hyperleukocytosis/trial eligibility), and/or leukapheresis, with a maximum limit of 1 month of exposure.

    • Note: White blood cell (WBC) must be < 25 x 10^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy.

  • Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy

  • Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H&P) exam completed within 14 days prior to registration

  • Participants must have a complete medical history and physical exam within 14 days prior to registration

  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration)

  • Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration

  • Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).

    • NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03

  • Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better

  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration

  • Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated

  • Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated

  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen

  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

  • Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications

  • Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy

  • Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted

    • Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH
    • In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants

  • Participants must be offered the opportunity to participate in specimen banking

  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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
Comparador Ativo: Arm 1 (ASTX727 + venetoclax)

Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
Procedimento: Bone Marrow Biopsy

Undergo bone marrow biopsy

Outros nomes:
  • Biópsia de Medula Óssea
  • Biópsia, Medula Óssea
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: Venetoclax

Given PO

Outros nomes:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Medicamento: Decitabine and Cedazuridine

Given PO

Outros nomes:
  • ASTX727
  • Inibidor de CDA E7727/agente de combinação decitabina ASTX727
  • Agente Combinado Cedazuridina/Decitabina ASTX727
  • Cedazuridina/Decitabina Comprimido
  • Inqovi
  • C-DEC
  • DEZ-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Experimental: Arm 2 (ASTX727 + venetoclax + enasidenib)

Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
Procedimento: Bone Marrow Biopsy

Undergo bone marrow biopsy

Outros nomes:
  • Biópsia de Medula Óssea
  • Biópsia, Medula Óssea
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: Venetoclax

Given PO

Outros nomes:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Medicamento: Decitabine and Cedazuridine

Given PO

Outros nomes:
  • ASTX727
  • Inibidor de CDA E7727/agente de combinação decitabina ASTX727
  • Agente Combinado Cedazuridina/Decitabina ASTX727
  • Cedazuridina/Decitabina Comprimido
  • Inqovi
  • C-DEC
  • DEZ-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Medicamento: Enasidenib

Given PO

Outros nomes:
  • AG-221
  • CC-90007 Base Gratuita
  • AG 221
  • AG221

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Minimal residual disease negative (MRDneg) complete remission (CR) rate
Prazo: Baseline to 5 years

A randomized design will be used to compare binary endpoints in two arms with a single interim futility analysis. For the final analysis, a 2-sample proportion z-test will be used to compare the MRDneg-CR+complete remission with partial hematologic recovery (CRh) rates between arms with a two-sided alpha of 20%.
Baseline to 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Relapse-free survival (RFS)
Prazo: Baseline to 5 years

Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Landmark Kaplan-Meier plots will be used describe marker associations with overall survival (OS) and RFS. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Baseline to 5 years
Event-free survival
Prazo: Baseline to 5 years

Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Molecular and flow MRD rates in the peripheral blood will be tabulated and summarized by arm. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Baseline to 5 years
Duration of response
Prazo: Baseline to 5 years

Response and toxicity rates will be tabulated. Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Baseline to 5 years
OS
Prazo: Baseline to 5 years

Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Molecular and flow MRD rates in the peripheral blood will be tabulated and summarized by arm. Landmark Kaplan-Meier plots will be used describe marker associations with OS and RFS. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Baseline 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: Eric J Huselton, SWOG Cancer Research Network

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)

16 de maio de 2025

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de novembro de 2024

Primeira postagem (Real)

4 de novembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de outubro de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2024-08951
  • U10CA180888 (Concessão/Contrato do NIH dos EUA)
  • NCI-2024-08951 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • MM1OA-S03 (Outro identificador: CTEP)
  • MM1OA-S03 (Outro identificador: SWOG)

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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