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Vergelijking van nieuwe behandelingen voor mensen met nieuw gediagnosticeerde acute myeloïde leukemie met een IDH2-genverandering (een MyeloMATCH-behandelingsproef)

24 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)

Een gerandomiseerd fase II-onderzoek met oraal decitabine en cedazuridine en Venetoclax vergeleken met oraal decitabine en cedazuridine, Venetoclax en enasidenib voor nieuw gediagnosticeerde oudere volwassenen met IDH2-mutante acute myeloïde leukemie: een MyeloMATCH-behandelingsonderzoek

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

93

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere namen:
  • Biopsie van beenmerg
  • Biopsie, beenmerg
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Geneesmiddel: Venetoclax

Given PO

Andere namen:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Geneesmiddel: Decitabine and Cedazuridine

Given PO

Andere namen:
  • ASTX727
  • CDA-remmer E7727/decitabine combinatiemiddel ASTX727
  • Cedazuridine/Decitabine Combinatiemiddel ASTX727
  • Cedazuridine/Decitabine-tablet
  • Inqovi
  • C-DEC
  • DEC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Experimenteel: 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.
Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Andere namen:
  • Biopsie van beenmerg
  • Biopsie, beenmerg
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Geneesmiddel: Venetoclax

Given PO

Andere namen:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Geneesmiddel: Decitabine and Cedazuridine

Given PO

Andere namen:
  • ASTX727
  • CDA-remmer E7727/decitabine combinatiemiddel ASTX727
  • Cedazuridine/Decitabine Combinatiemiddel ASTX727
  • Cedazuridine/Decitabine-tablet
  • Inqovi
  • C-DEC
  • DEC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Geneesmiddel: Enasidenib

Given PO

Andere namen:
  • AG-221
  • CC-90007 Vrije basis
  • AG221

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Minimal residual disease negative (MRDneg) complete remission (CR) rate
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relapse-free survival (RFS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Eric J Huselton, SWOG Cancer Research Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 mei 2025

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

1 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

1 november 2024

Eerst geplaatst (Werkelijk)

4 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

24 oktober 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2024-08951
  • U10CA180888 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2024-08951 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • MM1OA-S03 (Andere identificatie: CTEP)
  • MM1OA-S03 (Andere identificatie: SWOG)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren