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Confronto tra nuovi trattamenti per persone affette da leucemia mieloide acuta di nuova diagnosi che presenta una modificazione del gene IDH2 (uno studio di trattamento MyeloMATCH)

24 ottobre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase II su decitabina orale, cedazuridina e Venetoclax rispetto a decitabina orale, cedazuridina, Venetoclax ed enasidenib negli anziani di nuova diagnosi affetti da leucemia mieloide acuta con mutazione IDH2: uno studio sul trattamento 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

93

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Reclutamento
        • Centro Comprensivo de Cancer de UPR
        • Investigatore principale:
          • Luis J. Santos Reyes
        • Contatto:
      • San Juan, Porto Rico, 00936
        • Reclutamento
        • San Juan City Hospital
        • Investigatore principale:
          • Luis J. Santos Reyes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 787-763-1296
  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Reclutamento
        • Banner University Medical Center - Tucson
        • Investigatore principale:
          • Sharad Khurana
        • Contatto:
      • Tucson, Arizona, Stati Uniti, 85719
        • Reclutamento
        • University of Arizona Cancer Center-North Campus
        • Investigatore principale:
          • Sharad Khurana
        • Contatto:
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Reclutamento
        • University of Arkansas for Medical Sciences
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 501-686-8274
        • Investigatore principale:
          • Ankur Varma
    • California
      • Berkeley, California, Stati Uniti, 94704
        • Attivo, non reclutante
        • Alta Bates Summit Medical Center-Herrick Campus
      • San Francisco, California, Stati Uniti, 94143
        • Reclutamento
        • UCSF Medical Center-Parnassus
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-827-3222
        • Investigatore principale:
          • Timothy Ferng
      • San Mateo, California, Stati Uniti, 94401
        • Attivo, non reclutante
        • Mills Health Center
    • Florida
      • Hollywood, Florida, Stati Uniti, 33021
        • Sospeso
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Miami, Florida, Stati Uniti, 33176
        • Reclutamento
        • Miami Cancer Institute
        • Investigatore principale:
          • Firas El Chaer
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 786-596-2000
      • Pembroke Pines, Florida, Stati Uniti, 33028
        • Reclutamento
        • Memorial Hospital West
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 954-265-4325
        • Investigatore principale:
          • Stanislav Ivanov
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30912
        • Reclutamento
        • Augusta University Medical Center
        • Investigatore principale:
          • Vamsi Kota
        • Contatto:
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712
        • Reclutamento
        • Saint Luke's Cancer Institute - Boise
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Coeur d'Alene, Idaho, Stati Uniti, 83814
        • Reclutamento
        • Kootenai Health - Coeur d'Alene
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Fruitland, Idaho, Stati Uniti, 83619
        • Reclutamento
        • Saint Luke's Cancer Institute - Fruitland
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Meridian, Idaho, Stati Uniti, 83642
        • Reclutamento
        • Saint Luke's Cancer Institute - Meridian
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Luke's Cancer Institute - Nampa
        • Contatto:
        • Investigatore principale:
          • Charles W. Drescher
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Post Falls, Idaho, Stati Uniti, 83854
        • Reclutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Reclutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • University of Chicago Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern University
        • Contatto:
        • Investigatore principale:
          • Himachandana Atluri
      • Chicago, Illinois, Stati Uniti, 60612
        • Reclutamento
        • University of Illinois
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-355-3046
        • Investigatore principale:
          • Noah Birch
      • DeKalb, Illinois, Stati Uniti, 60115
        • Reclutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contatto:
        • Investigatore principale:
          • Himachandana Atluri
      • Evanston, Illinois, Stati Uniti, 60201
        • Reclutamento
        • NorthShore University HealthSystem-Evanston Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • David L. Grinblatt
      • Geneva, Illinois, Stati Uniti, 60134
        • Reclutamento
        • Northwestern Medicine Cancer Center Delnor
        • Contatto:
        • Investigatore principale:
          • Himachandana Atluri
      • Glenview, Illinois, Stati Uniti, 60026
        • Reclutamento
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • David L. Grinblatt
      • Glenview, Illinois, Stati Uniti, 60026
        • Reclutamento
        • Northwestern Medicine Glenview Outpatient Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
        • Investigatore principale:
          • Himachandana Atluri
      • Grayslake, Illinois, Stati Uniti, 60030
        • Reclutamento
        • Northwestern Medicine Grayslake Outpatient Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
        • Investigatore principale:
          • Himachandana Atluri
      • Highland Park, Illinois, Stati Uniti, 60035
        • Reclutamento
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • David L. Grinblatt
      • Hines, Illinois, Stati Uniti, 60141
        • Reclutamento
        • Edward Hines Jr VA Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 708-202-8387
        • Investigatore principale:
          • Jorgena Kosti-Schwartz
      • Lake Forest, Illinois, Stati Uniti, 60045
        • Reclutamento
        • Northwestern Medicine Lake Forest Hospital
        • Contatto:
        • Investigatore principale:
          • Himachandana Atluri
      • Maywood, Illinois, Stati Uniti, 60153
        • Reclutamento
        • Loyola University Medical Center
        • Investigatore principale:
          • Stephanie B. Tsai
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 708-226-4357
      • New Lenox, Illinois, Stati Uniti, 60451
        • Reclutamento
        • UC Comprehensive Cancer Center at Silver Cross
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • Orland Park, Illinois, Stati Uniti, 60462
        • Reclutamento
        • University of Chicago Medicine-Orland Park
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • Orland Park, Illinois, Stati Uniti, 60462
      • Warrenville, Illinois, Stati Uniti, 60555
        • Reclutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Contatto:
        • Investigatore principale:
          • Himachandana Atluri
    • Indiana
      • Crown Point, Indiana, Stati Uniti, 46307
        • Reclutamento
        • UChicago Medicine Northwest Indiana
        • Investigatore principale:
          • Olatoyosi M. Odenike
        • Contatto:
    • Kansas
      • Fairway, Kansas, Stati Uniti, 66205
        • Reclutamento
        • University of Kansas Clinical Research Center
        • Investigatore principale:
          • Kenneth Byrd
        • Contatto:
      • Kansas City, Kansas, Stati Uniti, 66160
        • Reclutamento
        • University of Kansas Cancer Center
        • Investigatore principale:
          • Kenneth Byrd
        • Contatto:
      • Westwood, Kansas, Stati Uniti, 66205
        • Reclutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Investigatore principale:
          • Kenneth Byrd
        • Contatto:
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • The James Graham Brown Cancer Center at University of Louisville
        • Investigatore principale:
          • Mohamed M. Hegazi
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 502-562-3429
      • Louisville, Kentucky, Stati Uniti, 40245
        • Reclutamento
        • UofL Health Medical Center Northeast
        • Investigatore principale:
          • Mohamed M. Hegazi
        • Contatto:
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70805
        • Reclutamento
        • LSU Health Baton Rouge-North Clinic
        • Contatto:
        • Investigatore principale:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Our Lady of The Lake
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 225-765-7659
        • Investigatore principale:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Our Lady of the Lake Physician Group
        • Contatto:
        • Investigatore principale:
          • Harry G. Sequeira Gross
    • Maine
      • Brunswick, Maine, Stati Uniti, 04011
        • Reclutamento
        • Mid Coast Hospital
        • Contatto:
        • Investigatore principale:
          • Pamela Egan
      • Brunswick, Maine, Stati Uniti, 04011
        • Reclutamento
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • Portland, Maine, Stati Uniti, 04102
        • Reclutamento
        • MaineHealth Maine Medical Center - Portland
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • Scarborough, Maine, Stati Uniti, 04074
        • Reclutamento
        • MaineHealth Maine Medical Center- Scarborough
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • South Portland, Maine, Stati Uniti, 04106
        • Reclutamento
        • MaineHealth Cancer Care and IV Therapy - South Portland
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
    • Michigan
      • Brighton, Michigan, Stati Uniti, 48114
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Canton, Michigan, Stati Uniti, 48188
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Chelsea, Michigan, Stati Uniti, 48118
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Attivo, non reclutante
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, Stati Uniti, 48202
        • Attivo, non reclutante
        • Henry Ford Hospital
      • Escanaba, Michigan, Stati Uniti, 49829
        • Reclutamento
        • OSF Saint Francis Hospital and Medical Group
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Genesys Hurley Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Flint, Michigan, Stati Uniti, 48503
        • Sospeso
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Cancer Hematology Centers - Flint
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Jackson, Michigan, Stati Uniti, 49201
        • Attivo, non reclutante
        • Allegiance Health
      • Livonia, Michigan, Stati Uniti, 48154
        • Reclutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • Novi, Michigan, Stati Uniti, 48377
        • Attivo, non reclutante
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, Stati Uniti, 48341
        • Reclutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Attivo, non reclutante
        • Henry Ford West Bloomfield Hospital
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contatto:
        • Investigatore principale:
          • Elie G. Dib
    • Minnesota
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Reclutamento
        • Mercy Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Deer River, Minnesota, Stati Uniti, 56636
        • Reclutamento
        • Essentia Health - Deer River Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Duluth, Minnesota, Stati Uniti, 55805
        • Reclutamento
        • Essentia Health Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Fairview Southdale Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Minnesota Oncology - Edina
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Hibbing, Minnesota, Stati Uniti, 55746
        • Reclutamento
        • Essentia Health Hibbing Clinic
        • Investigatore principale:
          • Bret E. Friday
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 218-786-3308
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Reclutamento
        • Abbott-Northwestern Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • Reclutamento
        • United Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Sandstone, Minnesota, Stati Uniti, 55072
        • Reclutamento
        • Essentia Health Sandstone
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Virginia, Minnesota, Stati Uniti, 55792
        • Reclutamento
        • Essentia Health Virginia Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
    • Montana
      • Anaconda, Montana, Stati Uniti, 59711
        • Reclutamento
        • Community Hospital of Anaconda
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59101
        • Reclutamento
        • Billings Clinic Cancer Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Bozeman, Montana, Stati Uniti, 59715
        • Reclutamento
        • Bozeman Health Deaconess Hospital
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Great Falls, Montana, Stati Uniti, 59405
        • Reclutamento
        • Benefis Sletten Cancer Institute
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Kalispell, Montana, Stati Uniti, 59901
        • Reclutamento
        • Logan Health Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Missoula, Montana, Stati Uniti, 59804
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Reclutamento
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contatto:
        • Investigatore principale:
          • Patrick W. Mellors
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Reclutamento
        • Memorial Sloan Kettering Basking Ridge
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • Livingston, New Jersey, Stati Uniti, 07039
        • Reclutamento
        • Cooperman Barnabas Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 973-322-5200
      • Long Branch, New Jersey, Stati Uniti, 07740
        • Reclutamento
        • Monmouth Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
      • Middletown, New Jersey, Stati Uniti, 07748
        • Reclutamento
        • Memorial Sloan Kettering Monmouth
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • Montvale, New Jersey, Stati Uniti, 07645
        • Reclutamento
        • Memorial Sloan Kettering Bergen
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Reclutamento
        • Rutgers Cancer Institute of New Jersey
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 732-235-7356
      • Toms River, New Jersey, Stati Uniti, 08755
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Reclutamento
        • University of New Mexico Cancer Center
        • Contatto:
        • Investigatore principale:
          • Charles Foucar
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Reclutamento
        • Roswell Park Cancer Institute
        • Investigatore principale:
          • Eunice S. Wang
        • Contatto:
      • Commack, New York, Stati Uniti, 11725
        • Reclutamento
        • Memorial Sloan Kettering Commack
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • Harrison, New York, Stati Uniti, 10604
        • Reclutamento
        • Memorial Sloan Kettering Westchester
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • New York, New York, Stati Uniti, 10065
        • Reclutamento
        • Memorial Sloan Kettering Cancer Center
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 585-275-5830
        • Investigatore principale:
          • Eric J. Huselton
      • Stony Brook, New York, Stati Uniti, 11794
        • Reclutamento
        • Stony Brook University Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-862-2215
        • Investigatore principale:
          • Suhu Liu
      • Syracuse, New York, Stati Uniti, 13210
        • Reclutamento
        • State University of New York Upstate Medical University
        • Investigatore principale:
          • Teresa C. Gentile
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 315-464-5476
      • Uniondale, New York, Stati Uniti, 11553
        • Reclutamento
        • Memorial Sloan Kettering Nassau
        • Investigatore principale:
          • Xin Wang
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28203
        • Reclutamento
        • Carolinas Medical Center/Levine Cancer Institute
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
        • Investigatore principale:
          • Brittany K. Ragon
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Investigatore principale:
          • Harry P. Erba
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
      • Greenville, North Carolina, Stati Uniti, 27834
        • Reclutamento
        • East Carolina University
        • Investigatore principale:
          • Darla K. Liles
        • Contatto:
      • Winston-Salem, North Carolina, Stati Uniti, 27157
        • Reclutamento
        • Wake Forest University Health Sciences
        • Investigatore principale:
          • Matthew J. Wieduwilt
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 336-713-6771
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Manu Pandey
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Sospeso
        • Oregon Health and Science University
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Reclutamento
        • Geisinger Medical Center
        • Investigatore principale:
          • Joseph J. Vadakara
        • Contatto:
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Thomas Jefferson University Hospital
        • Investigatore principale:
          • Lindsay Wilde
        • Contatto:
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • Reclutamento
        • UPMC Hillman Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-647-8073
        • Investigatore principale:
          • Annie P. Im
      • Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
        • Reclutamento
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contatto:
        • Investigatore principale:
          • Joseph J. Vadakara
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Reclutamento
        • Rhode Island Hospital
        • Investigatore principale:
          • John L. Reagan
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 401-444-1488
    • South Carolina
      • Boiling Springs, South Carolina, Stati Uniti, 29316
        • Reclutamento
        • Prisma Health Cancer Institute - Spartanburg
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Easley, South Carolina, Stati Uniti, 29640
        • Reclutamento
        • Prisma Health Cancer Institute - Easley
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Faris
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Butternut
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29615
        • Reclutamento
        • Prisma Health Cancer Institute - Eastside
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greer, South Carolina, Stati Uniti, 29650
        • Reclutamento
        • Prisma Health Cancer Institute - Greer
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Seneca, South Carolina, Stati Uniti, 29672
        • Reclutamento
        • Prisma Health Cancer Institute - Seneca
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920
        • Sospeso
        • University of Tennessee - Knoxville
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Reclutamento
        • Huntsman Cancer Institute/University of Utah
        • Contatto:
        • Investigatore principale:
          • Paul J. Shami
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigatore principale:
          • Keri R. Maher
        • Contatto:
    • Washington
      • Edmonds, Washington, Stati Uniti, 98026
        • Reclutamento
        • Swedish Cancer Institute-Edmonds
        • Investigatore principale:
          • Charles W. Drescher
        • Contatto:
      • Issaquah, Washington, Stati Uniti, 98029
        • Reclutamento
        • Swedish Cancer Institute-Issaquah
        • Investigatore principale:
          • Charles W. Drescher
        • Contatto:
      • Seattle, Washington, Stati Uniti, 98122
        • Reclutamento
        • Swedish Medical Center-First Hill
        • Investigatore principale:
          • Charles W. Drescher
        • Contatto:
    • Wisconsin
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Reclutamento
        • Duluth Clinic Ashland
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • Reclutamento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Reclutamento
        • Gundersen Lutheran Medical Center
        • Contatto:
        • Investigatore principale:
          • David E. Marinier
      • Madison, Wisconsin, Stati Uniti, 53705
        • Reclutamento
        • William S Middleton VA Medical Center
        • Investigatore principale:
          • Christopher D. Fletcher
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 17007 608-256-1901
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Medical College of Wisconsin
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 414-805-3666
        • Investigatore principale:
          • Guru Subramanian Guru Murthy
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Sheboygan, Wisconsin, Stati Uniti, 53081
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Sheboygan, Wisconsin, Stati Uniti, 53081
        • Reclutamento
        • Sheboygan Physicians Group
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Stevens Point, Wisconsin, Stati Uniti, 54482
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235-1495
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigatore principale:
          • Matthew L. Ryan
        • Contatto:
      • Weston, Wisconsin, Stati Uniti, 54476

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Droga: Venetoclax

Given PO

Altri nomi:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclixto
  • 199 circa
  • GDC 0199
  • GDC0199
Droga: Decitabine and Cedazuridine

Given PO

Altri nomi:
  • ASTX727
  • Inibitore CDA E7727/decitabina Agente di combinazione ASTX727
  • Agente combinato cedazuridina/decitabina ASTX727
  • Compressa di cedazuridina/decitabina
  • Inqovi
  • C-DEC
  • DIC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Sperimentale: 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.
Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Procedura: Bone Marrow Aspiration

Undergo bone marrow aspiration

Droga: Venetoclax

Given PO

Altri nomi:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclixto
  • 199 circa
  • GDC 0199
  • GDC0199
Droga: Decitabine and Cedazuridine

Given PO

Altri nomi:
  • ASTX727
  • Inibitore CDA E7727/decitabina Agente di combinazione ASTX727
  • Agente combinato cedazuridina/decitabina ASTX727
  • Compressa di cedazuridina/decitabina
  • Inqovi
  • C-DEC
  • DIC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Droga: Enasidenib

Given PO

Altri nomi:
  • AG-221
  • CC-90007 Base libera
  • AG221

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Minimal residual disease negative (MRDneg) complete remission (CR) rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Relapse-free survival (RFS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Eric J Huselton, SWOG Cancer Research Network

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 maggio 2025

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

1 novembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2024

Primo Inserito (Effettivo)

4 novembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 ottobre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2024-08951
  • U10CA180888 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2024-08951 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • MM1OA-S03 (Altro identificatore: CTEP)
  • MM1OA-S03 (Altro identificatore: SWOG)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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