En studie av bleximenib, venetoklaks og azacitidin for behandling av deltakere med akutt myeloid leukemi (AML) (cAMeLot-2)
2. november 2026 oppdatert av: Janssen Research & Development, LLC
En fase 3-randomisert, dobbeltblind, placebokontrollert, studie av bleximenib, venetoklaks og azacitidin for behandling av deltakere med nylig diagnostisert akutt myeloid leukemia som har KMT2A-omorganiseringer eller NPM1-mutasjoner som er ubetydelig for intensiv kjemoTaRance eller
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
600
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Bedford Park, Australia, 5042
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- Flinders Medical Centre
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Camperdown, Australia, 2050
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- Royal Prince Alfred Hospital
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Fitzroy, Australia, 3065
- Rekruttering
- St Vincents Hospital Melbourne
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Kogarah, Australia, 2217
- Rekruttering
- St George Hospital
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Melbourne, Australia, 3000
- Rekruttering
- Peter MacCallum Cancer Centre
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Woolloongabba, Australia, 4102
- Rekruttering
- Princess Alexandra Hospital
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Bruges, Belgia, 8000
- Rekruttering
- AZ Sint-Jan
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Edegem, Belgia, 2650
- Rekruttering
- UZ Antwerpen
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Genk, Belgia, 3600
- Rekruttering
- Ziekenhuis Oost-Limburg
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Ghent, Belgia, 9000
- Rekruttering
- Ghent University Hospital
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La Louvière, Belgia, 7100
- Rekruttering
- Chu Helora Hospital La Louviere Site Jolimont
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Leuven, Belgia, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Ottignies, Belgia, 1340
- Rekruttering
- Clinique Saint Pierre
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Roeselare, Belgia, 8800
- Rekruttering
- Algemeen Ziekenhuis Delta
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Barretos, Brasil, 14780 070
- Rekruttering
- Fundacao Pio XII
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Brasília, Brasil, 70390 700
- Rekruttering
- IDOR - Regional Brasilia
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Curitiba, Brasil, 81520-060
- Rekruttering
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Natal, Brasil, 59062 000
- Rekruttering
- Liga Norte Riograndense Contra O Cancer
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Rio de Janeiro, Brasil, 22775 001
- Rekruttering
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de Janeiro, Brasil, 20230 130
- Rekruttering
- Ministerio da Saude Instituto Nacional do Cancer
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São Paulo, Brasil, 05652 900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasil, 01323 010
- Rekruttering
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brasil, 01401 002
- Rekruttering
- IDOR - Regional Sao Paulo
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
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- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1N1
- Rekruttering
- Vancouver General Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Rekruttering
- Cancercare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Rekruttering
- Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Rekruttering
- Juravinski Cancer Centre
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Centre Victoria Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Aalborg, Danmark, 9000
- Rekruttering
- Aalborg University Hospital
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Copenhagen, Danmark, DK 2100
- Rekruttering
- Rigshospitalet
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Køge, Danmark, 4600
- Rekruttering
- Zealand University Hospital
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Odense, Danmark, 5000
- Rekruttering
- Odense University Hospital
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Rekruttering
- University of Alabama at Birmingham
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Arizona
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Goodyear, Arizona, Forente stater, 85338
- Rekruttering
- Cancer Treatment Center of America Phoenix
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Tucson, Arizona, Forente stater, 85724
- Rekruttering
- The University of Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72204
- Rekruttering
- University of Arkansas at Little Rock
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope
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Irvine, California, Forente stater, 92618
- Rekruttering
- City of Hope Orange County Lennar Foundation Cancer Center
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Rekruttering
- Rocky Mountain Cancer Centers
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Delaware
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Newark, Delaware, Forente stater, 19713
- Rekruttering
- Medical Oncology Hematology Consultants, PA
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Rekruttering
- Florida Cancer Specialists & Research Institute
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Jupiter, Florida, Forente stater, 33458
- Rekruttering
- Jupiter Research
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Orlando, Florida, Forente stater, 32806
- Rekruttering
- Orlando Health Cancer Institute
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Orlando, Florida, Forente stater, 32804
- Rekruttering
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando
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Pembroke Pines, Florida, Forente stater, 33026
- Rekruttering
- Memorial Cancer Institute
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffit Cancer center
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Weston, Florida, Forente stater, 33331
- Rekruttering
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago Medicine
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Niles, Illinois, Forente stater, 60714
- Rekruttering
- Illinois Cancer Specialists
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- Rekruttering
- University of Kentucky Markey Cancer Center
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Louisville, Kentucky, Forente stater, 40207
- Rekruttering
- Norton Cancer Institute
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Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- UofL Health Brown Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- Mary Bird Perkins Cancer Center
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Maine
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South Portland, Maine, Forente stater, 04106
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- MaineHealth Institute for Research
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Maryland
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Bethesda, Maryland, Forente stater, 20817
- Rekruttering
- Center for Cancer and Blood Disorders
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Rekruttering
- Henry Ford Health System
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Ypsilanti, Michigan, Forente stater, 48106
- Rekruttering
- Trinity Health Michigan Heart - Ann Arbor Campus
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Missouri
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St Louis, Missouri, Forente stater, 63130
- Rekruttering
- Washington University in St Louis
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Rekruttering
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Rekruttering
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, Forente stater, 14263
- Rekruttering
- Roswell Park Comprehensive Cancer Center
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forente stater, 10065
- Rekruttering
- New York Presbyterian - Weill Cornell
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Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester Medical Center
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Einstein-Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Atrium Health
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Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Novant Health Charlotte
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Charlotte, North Carolina, Forente stater, 28207
- Rekruttering
- Carolina Oncology Specialists
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Winston-Salem, North Carolina, Forente stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forente stater, 27106
- Rekruttering
- Novant Health Winston Salem
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Ohio
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Canton, Ohio, Forente stater, 44718
- Rekruttering
- Gabrail Cancer Center
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Centerville, Ohio, Forente stater, 45459
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- Miami Valley Hospital South
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Cincinnati, Ohio, Forente stater, 45226
- Rekruttering
- Oncology Hematology Care
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Cleveland, Ohio, Forente stater, 44106
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- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forente stater, 44195
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- Cleveland Clinic
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Oregon
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Portland, Oregon, Forente stater, 97213
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- Providence Portland Medical Center
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Portland, Oregon, Forente stater, 97225
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- Providence Oncology and Hematology Care Clinic Westside
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
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- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Forente stater, 15260
- Rekruttering
- University of Pittsburgh Medical Center
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Tennessee
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Knoxville, Tennessee, Forente stater, 37920
- Rekruttering
- University of Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt Ingram Cancer Center
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Texas
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Baylor University Medical Center
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Houston, Texas, Forente stater, 77030
- Rekruttering
- The University of Texas Health Science Center at Houston
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Houston, Texas, Forente stater, 77030
- Rekruttering
- MD Anderson Cancer Center
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Cancer Center
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Tyler, Texas, Forente stater, 75702
- Rekruttering
- Texas Oncology - Northeast
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Utah
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Salt Lake City, Utah, Forente stater, 84143
- Rekruttering
- Intermountain Healthcare LDS Hospital
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Virginia
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Richmond, Virginia, Forente stater, 23298
- Rekruttering
- Virginia Commonwealth University - Massey Cancer Center
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- Swedish Cancer Institute
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Seattle, Washington, Forente stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Center
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Angers, Frankrike, 49933
- Rekruttering
- CHU d'Angers
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Clermont-Ferrand, Frankrike, 63100
- Rekruttering
- CHU de Clermont Ferrand - Site Estaing
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Lille, Frankrike, 59020
- Rekruttering
- Hopital Saint Vincent de Paul
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Marseille, Frankrike, 13273
- Rekruttering
- Institut Paoli Calmettes
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Montpellier, Frankrike, 34295
- Rekruttering
- CHU de Montpellier Hopital Saint Eloi
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Nice, Frankrike, 06202
- Rekruttering
- CHU De Nice Hopital De l'Archet
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Paris, Frankrike, 75010
- Rekruttering
- Hopital Saint Louis
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Pierre-Bénite, Frankrike, 69310
- Rekruttering
- CHU Lyon Sud
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Reims, Frankrike, 51100
- Rekruttering
- CHU Reims Hopital Robert Debre
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Rennes, Frankrike, 35000
- Rekruttering
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankrike, 31100
- Rekruttering
- Institut Universitaire du Cancer Toulouse Oncopole
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Vandœuvre Ies-Nancy, Frankrike, 54500
- Rekruttering
- CHRU de Nancy - Hopitaux de Brabois
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Villejuif, Frankrike, 94805
- Rekruttering
- Institut Gustave Roussy
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Alexandroupoli, Hellas, 68100
- Rekruttering
- University Hospital of Alexandroupolis
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Athens, Hellas, 106 76
- Rekruttering
- Evaggelismos Hospital
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Chaïdári, Hellas, 124 62
- Rekruttering
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Ioannina, Hellas, 455 00Q
- Rekruttering
- University General Hospital of Ioannina
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Rio, Hellas, 265 04
- Rekruttering
- General University Hospital of Patras
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Thessaloniki, Hellas, 570 10
- Rekruttering
- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Hellas, 54636
- Rekruttering
- Ahepa University General Hospital of Thessaloniki
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Hong Kong, Hong Kong
- Rekruttering
- Queen Mary Hospital
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Beer Yaakov, Israel, 7033001
- Rekruttering
- Shamir Medical Center Assaf Harofeh
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Medical Center
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Haifa, Israel, 3436212
- Rekruttering
- Carmel Medical Center
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Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah University Hospita Ein Kerem
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Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center
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Ramat Gan, Israel, 5262000
- Rekruttering
- Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center
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Bergamo, Italia, 24127
- Rekruttering
- ASST Papa Giovanni XXIII Bergamo
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Bologna, Italia, 40138
- Rekruttering
- A O U Sant Orsola Malpighi
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Brescia, Italia, 25123
- Rekruttering
- Azienda Ospedaliera Spedali Civili di Brescia
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Meldola, Italia, 47014
- Rekruttering
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italia, 20162
- Rekruttering
- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Pavia, Italia, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italia, 06132
- Rekruttering
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
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Pesaro, Italia, 61121
- Rekruttering
- AST Pesaro e Urbino Ospedale San Salvatore
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Ravenna, Italia, 48121
- Rekruttering
- Ospedale S. Maria Delle Croci
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Reggio Calabria, Italia, 89124
- Rekruttering
- Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
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Rozzano, Italia, 20089
- Rekruttering
- IRCCS Istituto Clinico Humanitas
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San Giovanni Rotondo, Italia, 71013
- Rekruttering
- Casa Sollievo Della Sofferenza IRCCS
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Torino, Italia, 10126
- Rekruttering
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Bunkyō City, Japan, 113 8677
- Rekruttering
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Fukuoka, Japan, 812 8582
- Rekruttering
- Kyushu University Hospital
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Fukushima, Japan, 960 1295
- Rekruttering
- Fukushima Medical University Hospital
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Gifu, Japan, 500-8513
- Rekruttering
- Gifu Municipal Hospital
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Kanazawa, Japan, 920-8641
- Rekruttering
- Kanazawa University Hospital
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Kobe, Japan, 650 0047
- Rekruttering
- Kobe City Medical Center General Hospital
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Kumamoto, Japan, 860-0008
- Rekruttering
- National Hospital Organization Kumamoto Medical Center
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Maebashi, Japan, 371-0821
- Rekruttering
- Gunmaken Saiseikai Maebashi Hospital
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Nagoya, Japan, 466 8560
- Rekruttering
- Nagoya University Hospital
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Okayama, Japan, 700 8558
- Rekruttering
- Okayama University Hospital
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Osaka, Japan, 543 8555
- Rekruttering
- Japanese Red Cross Osaka Hospital
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Sapporo, Japan, 064 0804
- Rekruttering
- Aiiku Hospital
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Sendai, Japan, 980 8574
- Rekruttering
- Tohoku University Hospital
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Tokyo, Japan, 113 8603
- Rekruttering
- Nippon Medical School Hospital
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Tsukuba, Japan, 305-8576
- Rekruttering
- University of Tsukuba Hospital
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Yamagata, Japan, 990 2331
- Rekruttering
- Yamagata University Hospital
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Yoshida, Japan, 910-1193
- Rekruttering
- University of Fukui Hospital
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Beijing, Kina, 100191
- Rekruttering
- Peking University Third Hospital
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Beijing, Kina, 100044
- Rekruttering
- Peking University People's Hospital
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Beijing, Kina, 100020
- Rekruttering
- Peking University First Hospital
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Changchun, Kina, 130021
- Rekruttering
- The first Affiliated Hospital of Jilin University
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Chengdu, Kina, 610032
- Rekruttering
- Sichuan Provincial Peoples Hospital
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital Si Chuan University
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Chongqing, Kina, 401147
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou, Kina, 510060
- Rekruttering
- Sun Yat Sen University Cancer Center
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Hangzhou, Kina, 310003
- Rekruttering
- The First Affiliated Hospital Zhejiang University College of Medicine
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Hefei, Kina, 230001
- Rekruttering
- The First Affiliated Hospital of USTC Anhui Provincial Hospital
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Jinan, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
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Lanzhou, Kina, 730030
- Rekruttering
- The Second Hospital & Clinical Medical School Lanzhou University
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Nanchang, Kina, 330006
- Rekruttering
- The First Affiliated Hospital of NanChang University
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Nanjing, Kina, 210009
- Rekruttering
- Zhongda Hospital Southeast University
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Nanning, Kina, 530021
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
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Shenyang, Kina, 110055
- Rekruttering
- Shengjing Hospital Of China Medical University
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Shenzhen, Kina, 518035
- Rekruttering
- The Second People's Hospital of Shenzhen
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Suzhou, Kina, 215005
- Rekruttering
- First Affiliated Hospital SooChow University
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Tijian, Kina, 300020
- Rekruttering
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
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Wenzhou, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430030
- Rekruttering
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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Wuhan, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Xi'an, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xiamen, Kina, 361003
- Rekruttering
- The first affiliated hospital of xiamen university
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Zhengzhou, Kina, 450008
- Rekruttering
- Henan Cancer Hospital
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Mexico City, Mexico, 14080
- Rekruttering
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City, Mexico, 14080
- Rekruttering
- Instituto Nacional de Cancerologia
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Mexico City, Mexico, 04100
- Rekruttering
- Centro de Investigacion Clinica Chapultepec
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Bialystok, Polen, 15 276
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz, Polen, 85-168
- Rekruttering
- Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
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Gdansk, Polen, 80 214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
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Kielce, Polen, 25 734
- Rekruttering
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Lodz, Polen, 93 513
- Rekruttering
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
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Wroclaw, Polen, 50 367
- Rekruttering
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Lisbon, Portugal, 1169 050
- Rekruttering
- Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
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Lisbon, Portugal, 1649 028
- Rekruttering
- Uls Santa Maria Hosp. Santa Maria
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Porto, Portugal, 4200 319
- Rekruttering
- Uls Sao Joao - Hosp. Sao Joao
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Porto, Portugal, 4099 001
- Rekruttering
- Uls Santo Antonio - Hosp. Santo Antonio
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Porto, Portugal, 4200 072
- Rekruttering
- Instituto Portugues de Oncologia Porto
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A Coruña, Spania, 15006
- Rekruttering
- Hosp Univ A Coruna
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Barcelona, Spania, 08041
- Rekruttering
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spania, 08036
- Rekruttering
- Hosp. Clinic de Barcelona
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Barcelona, Spania, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
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Cáceres, Spania, 10003
- Rekruttering
- Hosp. San Pedro de Alcantara
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Jerez de la Frontera, Spania, 11407
- Rekruttering
- Hosp. de Jerez de La Frontera
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L'Hospitalet de Llobregat, Spania, 08908
- Rekruttering
- Inst. Cat. Doncologia-H Duran I Reynals
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Madrid, Spania, 28034
- Rekruttering
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spania, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spania, 28027
- Rekruttering
- Clinica Univ. de Navarra Madrid
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Pamplona, Spania, 31008
- Rekruttering
- Clinica Univ. de Navarra
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Pozuelo de Alarcón, Spania, 28223
- Rekruttering
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spania, 37007
- Rekruttering
- Hosp Clinico Univ de Salamanca
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Santander, Spania, 39008
- Rekruttering
- Hosp. Univ. Marques de Valdecilla
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Seville, Spania, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Valencia, Spania, 46026
- Rekruttering
- Hosp. Univ. I Politecni La Fe
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-
-
-
-
Brighton, Storbritannia, BN2 5BE
- Rekruttering
- Royal Sussex County Hospital
-
Cambridge, Storbritannia, CB2 0QQ
- Rekruttering
- Addenbrookes Hospital
-
Canterbury, Storbritannia, CT1 3NG
- Rekruttering
- Kent and Canterbury Hospital
-
Colchester, Storbritannia, CO4 5JL
- Rekruttering
- Colchester Hospital University NHS
-
Edinburgh, Storbritannia, EH4 2XU
- Rekruttering
- Western General Hospital
-
Liverpool, Storbritannia, L7 8YA
- Rekruttering
- The Clatterbridge Cancer Centre
-
London, Storbritannia, SE1 9RT
- Rekruttering
- Guys' and St Thomas' NHS Trust
-
Plymouth, Storbritannia, PL6 8DH
- Rekruttering
- Derriford Hospital
-
Worthing, Storbritannia, BN11 2DH
- Rekruttering
- Worthing Hospital
-
-
-
-
-
Daejeon, Sør -Korea, 35015
- Rekruttering
- Chungnam National University Hospital
-
Goyang-si, Sør -Korea, 10408
- Rekruttering
- National Cancer Center
-
Gyeonggi-do, Sør -Korea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sør -Korea, 137 701
- Rekruttering
- The Catholic University of Korea Seoul St Marys Hospital
-
-
-
-
-
Cape Town, Sør-Afrika, 7580
- Rekruttering
- Haemalife
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Rekruttering
- Kaohsiung Chang Gung Memorial Hospital
-
Tainan, Taiwan, 736
- Rekruttering
- Chi Mei Medical Center Liouying Branch
-
Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
-
Taoyuan, Taiwan, 333
- Rekruttering
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Brno, Tsjekkia, 625 00
- Rekruttering
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
-
Hradec Králové, Tsjekkia, 500 05
- Rekruttering
- Fakultni nemocnice Hradec Kralove
-
Ostrava - Poruba, Tsjekkia, 708 52
- Rekruttering
- Fakultni Nemocnice Ostrava
-
Pilsen, Tsjekkia, 304 60
- Rekruttering
- Fakultni nemocnice Plzen
-
Prague, Tsjekkia, 100 00
- Rekruttering
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tsjekkia, 128 00
- Rekruttering
- Ustav Hematologie A Krevni Transfuze
-
Prague, Tsjekkia, 128 08
- Rekruttering
- Vseobecna Fakultní Nemocnice
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 06200
- Rekruttering
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Tyrkia (Türkiye), 06170
- Rekruttering
- Ankara Etlik Sehir Hastanesi
-
Ankara, Tyrkia (Türkiye), 06590
- Rekruttering
- Ankara University School of Medicine Cebeci Hospital
-
Antalya, Tyrkia (Türkiye), 07025
- Rekruttering
- Memorial Antalya Hospital
-
Istanbul, Tyrkia (Türkiye), 34010
- Rekruttering
- Koc University Medical Faculty
-
Mersin, Tyrkia (Türkiye), 33200
- Rekruttering
- VM Medical Park Mersin Hospital
-
Sakarya, Tyrkia (Türkiye), 54100
- Rekruttering
- Sakarya University Training and Research Hospital
-
Samsun, Tyrkia (Türkiye), 55139
- Rekruttering
- Ondokuz Mayis University
-
-
-
-
-
Augsburg, Tyskland, 86156
- Rekruttering
- Klinikum Augsburg
-
Cologne, Tyskland, 50937
- Rekruttering
- Universitaetsklinikum Koeln
-
Dresden, Tyskland, 01307
- Rekruttering
- Universitaetsklinikum Carl Gustav Carus TU Dresden
-
Frankfurt, Tyskland, 60590
- Rekruttering
- Universitaetsklinikum Frankfurt
-
Freiburg im Breisgau, Tyskland, 79106
- Rekruttering
- Universitaetsklinikum Freiburg
-
Hamburg, Tyskland, 20246
- Rekruttering
- Universitaetsklinikum Hamburg Eppendorf
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg
-
Kiel, Tyskland, 24105
- Rekruttering
- Universitaetsklinikum Schleswig Holstein Campus Kiel
-
Leipzig, Tyskland, 04103
- Rekruttering
- Universitaetsklinikum Leipzig
-
München, Tyskland, 81377
- Rekruttering
- Klinikum der Universitaet Muenchen
-
Würzburg, Tyskland, 97080
- Rekruttering
- Universitaetsklinikum Wuerzburg
-
-
-
-
-
Budapest, Ungarn, 1088
- Rekruttering
- Semmelweis Egyetem
-
Budapest, Ungarn, 1097
- Rekruttering
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
-
Debrecen, Ungarn, 4032
- Rekruttering
- Debreceni Egyetem Klinikai Kozpont
-
Győr, Ungarn, 9024
- Rekruttering
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
-
Pécs, Ungarn, 7624
- Rekruttering
- Pecsi Tudomanyegyetem Klinikai Kozpont
-
Szeged, Ungarn, 6725
- Rekruttering
- SZTE Szent-Gyorgyi Albert Klinikai Kozpont
-
-
-
-
-
Linz, Østerrike, 4020
- Rekruttering
- Ordensklinikum Linz GmbH Elisabethinen
-
Linz, Østerrike, 4020
- Rekruttering
- Kepler Universitatsklinikum GmbH
-
Salzburg, Østerrike, 5020
- Rekruttering
- Universitaetsklinikum Salzburg Landeskrankenhaus
-
Vienna, Østerrike, 1130
- Rekruttering
- Wiener Gesundheitsverbund Klinik Hietzing
-
Vienna, Østerrike, 1090
- Rekruttering
- Medical University of Vienna Universitatsklinik fur Innere Medizin I
-
Wels, Østerrike, 4600
- Rekruttering
- Klinikum Wels Grieskirchen
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Be 18 years of age or older at the time of informed consent
- Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
- Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
- Participants must have adequate hepatic and renal function
- A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
- A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
- Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria:
- Diagnosis of acute promyelocytic leukemia (APL)
- Known active leukemic involvement of the central nervous system (CNS)
- Recipient of solid organ transplant
- Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
- Active infectious hepatitis
- Live, attenuated vaccine within 4 weeks of randomization
- Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)
Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity. |
Bleximenib will be administered orally.
Andre navn:
VEN will be administered orally. AZA will be administered intravenously or subcutaneously. |
|
Placebo komparator: Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)
Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity. |
Placebo will be administered orally. VEN will be administered orally. AZA will be administered intravenously or subcutaneously. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants who Achieve Complete Remission (CR)
Tidsramme: Up to 4 years and 1 month
|
CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 * 10^9/Liter (1,000/microliter [mcL]); Platelet count >= 100 * 10^9/L (100,000/mcL). |
Up to 4 years and 1 month
|
|
Overall Survival (OS)
Tidsramme: Up to 4 years and 1 month
|
Overall survival time is defined as the time duration from the date of randomization to death due to any cause. |
Up to 4 years and 1 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-free survival (EFS)
Tidsramme: Up to 4 years and 1 month
|
EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first. |
Up to 4 years and 1 month
|
|
Duration of CR
Tidsramme: Up to 4 years and 1 month
|
Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively. |
Up to 4 years and 1 month
|
|
Time to CR
Tidsramme: Up to 4 years and 1 month
|
Time to CR is defined as time from randomization to first documented response. |
Up to 4 years and 1 month
|
|
Rate of CR Without Measurable Residual Disease (MRD-)
Tidsramme: Up to 4 years and 1 month
|
Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD. |
Up to 4 years and 1 month
|
|
Percentage of Participants who Achieved Transfusion Independence
Tidsramme: Up to 4 years and 1 month
|
Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period. |
Up to 4 years and 1 month
|
|
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Tidsramme: Up to 4 years and 1 month
|
Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization. |
Up to 4 years and 1 month
|
|
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to 4 years and 1 month
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 4 years and 1 month
|
|
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Tidsramme: Up to 4 years and 1 month
|
Participants with abnormalities in clinical laboratory parameters will be reported. |
Up to 4 years and 1 month
|
|
Serum Concentration of Bleximenib
Tidsramme: Up to 4 years and 1 month
|
Serum samples will be analyzed to determine concentrations of bleximenib. |
Up to 4 years and 1 month
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. juni 2025
Primær fullføring (Antatt)
22. juni 2029
Studiet fullført (Antatt)
15. august 2029
Datoer for studieregistrering
Først innsendt
25. februar 2025
Først innsendt som oppfylte QC-kriteriene
25. februar 2025
Først lagt ut (Faktiske)
28. februar 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Leukemi, myeloid
- Leukemi
- Hemic og lymfatiske sykdommer
- Leukemi, Myeloid, Akutt
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Nukleinsyrer, nukleotider og nukleosider
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- AZA -forbindelser
- Nukleosider
- Ribonukleosider
- Azacitidin
- Venetoclax
Andre studie-ID-numre
- 75276617AML3001
- 75276617AML3001 (Annen identifikator: Janssen Research & Development, LLC)
- 2024-520154-38-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .