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Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Sponsor: Kura Oncology, Inc.
Summary
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".
Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1300
Start Date
2025-09-26
Completion Date
2031-11
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Ziftomenib
Oral administration
Placebo
Oral administration
Venetoclax
Oral administration
Azacitidine (AZA)
Intravenous or subcutaneous administration
Daunorubicin
Intravenous administration
Cytarabine (Ara-C)
Intravenous administration
Locations (136)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of California, Fresno
Clovis, California, United States
University of California, San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Hartford HealthCare Cancer Institute
Hartford, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Fairway, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
HealthPartners Cancer Center at Regions Hospital (MN)
Saint Paul, Minnesota, United States
Rutgers Biomedical and Health Sciences
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
State University of New York at Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology-Presbyterian Cancer Center
Dallas, Texas, United States
University of Texas
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Manassas, Virginia, United States
WVU Medicine Wheeling Hospital
Wheeling, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Gachon University Gil Medical Center
Kurralta Park, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Box Hill Hospital
Heidelberg, Victoria, Australia
Northern Health Epping
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Centre Hospitalier Régional Verviers East Belgium
Verviers, Walloonia, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta VZW
Roeselare, West-Vlaanderen, Belgium
Gordon and Leslie Diamond Health Cancer Centre-Leukemia/BMT Program of BC
Vancouver, British Columbia, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Moravian-Silesian, Czechia
Fakultní Nemocnice Královské Vinohrady
Prague, Prague, Czechia
Centre Hospitalier Universitaire Estaing - Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
Hôpital Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller
Mulhouse, Grand Est, France
Centre Hospitalier Régional et Universitaire de Nancy Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Grand Est, France
Centre Hospitalier Universitaire de Nantes
Nantes, Loire-Atlantique, France
Centre Hospitalier Universitaire de Bordeaux
Pessac, New Aquitaine, France
Centre Hospitalier de Roubaix
Lille, Nord, France
Centre Henri Becquerel
Rouen, Normandy, France
Centre Hospitalier de Béziers
Béziers, Occitanie, France
Centre Hospitalier Universitaire de Marseille - Hôpital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Universitaire Henri Mondor
Créteil, Val-de-Marne, France
Institut Gustave Roussy
Villejuif, Val-De-Marne, France
Hôpital Avicenne
Bobigny, Île-de-France Region, France
Centre Hospitalier de Versailles
Le Chesnay, Île-de-France Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, France
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, France
Helios Klinikum Bad Saarow
Bad Saarow, Brandenburg, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Laiko General Hospital of Athens
Athens, Attica, Greece
Attikon University General Hospital of Athens
Chaïdári, Attica, Greece
General Hospital of Thessaloniki G. Papanikolaou
Exochi, Central Macedonia, Greece
University General Hospital of Alexandroupoli
Alexandroupoli, East Macedonia and Thrace, Greece
University General Hospital of Ioannina
Ioannina, Epirus, Greece
DPC-Hospital
Budapest, Budapest, Hungary
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Gyor-Moson-Sopron County, Hungary
Kaposi Mor County Hospital
Kaposvár, Somogy County, Hungary
L'IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria DI Modena
Modena, Emilia-Romagna, Italy
Hospital Santa Maria delle Croci
Ravenna, Emilia-Romagna, Italy
ASUGI Ospedale Maggiore di Trieste
Trieste, Friuli Venezia Giulia, Italy
ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Azienda Ospedaliera Universitaria SS Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy
Azienda Sanitaria Territoriale di Ascoli Piceno
Ascoli Piceno, The Marches, Italy
Azienda Ospedaliero-Universitaria
Perugia, Umbria, Italy
Ematologia Ospedale San Bortolo
Vicenza, Veneto, Italy
Baguio General Hospital and Medical Center
Baguio City, Benguet, Philippines
Perpetual Succour Hospital
Cebu City, Central Visayas, Philippines
Philippine General Hospital
Ermita, National Capital Region, Philippines