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Sammenligning af nye behandlinger for mennesker med nyligt diagnosticeret akut myeloid leukæmi, der har en IDH2-genændring (en MyeloMATCH-behandlingsforsøg)

24. oktober 2026 opdateret af: National Cancer Institute (NCI)

Et randomiseret fase II-forsøg med oral decitabin og Cedazuridin og Venetoclax sammenlignet med oral decitabin og Cedazuridin, Venetoclax og Enasidenib til nydiagnosticerede ældre voksne med IDH2-mutant akut myeloid leukæmi: Et MyeloMATCH-behandlingsforsøg

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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
93

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Aktiv komparator: 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

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicin: Venetoclax

Given PO

Andre navne:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Medicin: Decitabine and Cedazuridine

Given PO

Andre navne:
  • ASTX727
  • CDA-hæmmer E7727/Decitabin-kombinationsmiddel ASTX727
  • Cedazuridin/Decitabin kombinationsmiddel ASTX727
  • Cedazuridin/Decitabine tablet
  • Inqovi
  • C-DEC
  • DEC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Eksperimentel: 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

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Procedure: Bone Marrow Aspiration

Undergo bone marrow aspiration

Medicin: Venetoclax

Given PO

Andre navne:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Medicin: Decitabine and Cedazuridine

Given PO

Andre navne:
  • ASTX727
  • CDA-hæmmer E7727/Decitabin-kombinationsmiddel ASTX727
  • Cedazuridin/Decitabin kombinationsmiddel ASTX727
  • Cedazuridin/Decitabine tablet
  • Inqovi
  • C-DEC
  • DEC-C
  • ASTX 727
  • ASTX-727
  • Inaqovi
Medicin: Enasidenib

Given PO

Andre navne:
  • AG-221
  • CC-90007 fri base
  • AG 221
  • AG221

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Minimal residual disease negative (MRDneg) complete remission (CR) rate
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relapse-free survival (RFS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National Cancer Institute (NCI)

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Eric J Huselton, SWOG Cancer Research Network

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
16. maj 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. marts 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
31. marts 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
1. november 2024

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
1. november 2024

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
4. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
27. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
24. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NCI-2024-08951
  • U10CA180888 (U.S. NIH-bevilling/kontrakt)
  • NCI-2024-08951 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • MM1OA-S03 (Anden identifikator: CTEP)
  • MM1OA-S03 (Anden identifikator: SWOG)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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