Spots Global Cancer Trial Database for Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
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Trial Identification
Brief Title: Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
Official Title: A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia
Study ID: NCT04778397
Conditions
Study Description
Brief Summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
USC/ Norris Comprehensive Cancer Center, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UC Irvine Health, Orange, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Memorial Cancer Institute, Pembroke Pines, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern Memorial Hospital/Main Lab, Chicago, Illinois, United States
The University of Chicago Medical Centre, Chicago, Illinois, United States
University of Kansas Hospital, Fairway, Kansas, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Tulane Medical center, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester, Minnesota, United States
MidAmerica Division, Inc., c/o Research Medical Center, Kansas City, Missouri, United States
SSM Health Saint Louis University Hospital, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Blood Cancer Center, Durham, North Carolina, United States
The Ohio State University Wexner Medical Center/ James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States
St. Francis Cancer Center, Greenville, South Carolina, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Baylor College of Medicine Medical Center, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute ,The University of Utah, Salt Lake City, Utah, United States
Froedtert Hospital / Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Canberra Hospital, Garran, Australian Capital Territory, Australia
Calvary Master Newcastle, Waratah, New South Wales, Australia
Westmead Hospital / Department of Haematology and Bone Marrow Transplantation, Westmead, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Andrew Love Cancer Centre, University Hospital Geelong, Geelong, Victoria, Australia
The Alfred, Melbourne, Victoria, Australia
St Vincents Hospital Melbourne, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed, Linz, , Austria
Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU, Salzburg, , Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Universitair Ziekenhuis Brussel, Brussels, , Belgium
Grand Hôpital De Charleroi - Notre Dame, Charleroi, , Belgium
Universitaire Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
AZ Delta vzw, Roeselare, , Belgium
Tom Baker Cancer Center, Calgary, , Canada
Queen Elizabeth II Health Sciences Centre, Halifax, , Canada
CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont, Montreal, , Canada
McGill University Health Centre, Montreal, , Canada
Sunnybrook Research Institute, Toronto, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Aalborg University Hospital, Aalborg, , Denmark
Odense University Hospital, Odense C, , Denmark
CHU d'Angers, Angers cedex, , France
CHU de Caen, Caen cedex, , France
CHRU Lille - Hospital Claude Huriez, Lille, , France
CHU Limoges, Limoges, , France
Central Hospital Lyon Sud, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CHU de Nantes, Hotel Dieu, Nantes, , France
CHU Nice - Hopital Archet 1, Nice, , France
Gustave Roussy, Paris, , France
Hopital Haut-Leveque, Pessac, , France
IUCT Oncopole, Toulouse, , France
Hopitaux de Brabois, Vandoeuvre-lès-Nancy, , France
Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation, Aachen, , Germany
Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum, Berlin, , Germany
Department of Hematology and Oncology, Braunschweig Community Hospital, Braunschweig, , Germany
Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie, Dresden, , Germany
Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie, Dusseldorf, , Germany
Dept. of Medicine II, University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie, Heidelberg, , Germany
Universitatsklinikum Schleswig-Holstein, Kiel, , Germany
Universitatsklinikum Koln, Köln, , Germany
Klinikum Ludwigshafen Medizinische Klinik A, Ludwigshafen, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III, Muenchen, , Germany
LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern, München, , Germany
Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III, Ulm, , Germany
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Azienda Ospedaliero Universitaria delle Marche, Ancona, , Italy
AOU Consorziale Policlinico Bari, Bari, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia, Bologna, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica, Meldola, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo, Napoli, , Italy
SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia, Perugia, , Italy
AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia, Pesaro, , Italy
Fondazione PTV Policinico Tor Vergata, Roma, , Italy
SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino, Torino, , Italy
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, , Japan
Chiba Aoba Municipal Hospital, Chiba, , Japan
University of Yamanashi Hospital, Chuo-City, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Fukushima Medical University Hospital, Fukushima-Shi, , Japan
Aiiku Hospital, Hokkaido, , Japan
Tokai University School of Medicine, Isehara, , Japan
Kanazawa University Hospital, Kanazawa, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Hospital of the University of Occupational and Environmental Health, Japan, Kitakyushu-shi, , Japan
Kobe City Medical Center General Hospital, Kobe-city, , Japan
Gunmaken Saiseikai Maebashi Hospital, Maebashi, , Japan
Ehime Prefectural Center Hospital, Matsuyama, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya-Shi, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, , Japan
Okayama University Hospital, Okayama-Shi, , Japan
Osaka Metropolitan University Hospital, Osaka-Shi, , Japan
Kindai University Hospital, Osakasayama, , Japan
National University Corporation Tohoku University Tohoku University Hospital, Sendai, , Japan
NTT Medical Center Tokyo, Shinagawa-Ku, , Japan
Yamagata University Hospital, Yamagata, , Japan
University of Fukui Hospital, Yoshida-gun, , Japan
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital del la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Institut Catala d'Oncologia, Barcelona, , Spain
Complejo Asistencial Universitario de Burgos/H.U. de Burgos, Burgos, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Complejo Hospitalario San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Clinica Universidad de Navarra - Pamplona (Main Site), Pamplona, , Spain
Complejo Asistencial Universitario de Salamanca - Hsopital Clinico, Salamanca, , Spain
Hospital U. Marques de Valdecilla, Santander, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitari I Politècnic La Fe, Valencia, , Spain
Universitetssjukhus, Hematologimottagnungen, Lund, , Sweden
Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin, Basel, , Switzerland
Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie, Berne, , Switzerland
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road, Boston, , United Kingdom
Cambridge University Hospital NHS Foundation Trust, Cambridge, , United Kingdom
Cardiff and Vale University Health Board, Cardiff Wales, , United Kingdom
Barts Health NHS Trust, City of London, , United Kingdom
NHS Tayside, Dundee, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
King's College NHS Foundation Trust, London, , United Kingdom
Oxford University Hospital NHS Foundation Trust, Oxford, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
The Christie NHS Foundation Trust, Withington, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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