Spots Global Cancer Trial Database for Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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Trial Identification
Brief Title: Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title: A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Study ID: NCT02785900
Conditions
Study Description
Brief Summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.
Detailed Description: Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo. Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope National Medical Center, Duarte, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Florida Cancer Specialists - South Region, Fort Myers, Florida, United States
Shands Cancer Center / University of Florida, Gainesville, Florida, United States
Memorial Cancer Institute, Miami, Florida, United States
Florida Center for Cellular Therapy / Blood and Marrow Transplant Center, Orlando, Florida, United States
Florida Cancer Specialists - North Region, Saint Petersburg, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
OnCare Hawaii, Honolulu, Hawaii, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
LSU Health Sciences Center / Feist Weiller Cancer Center, Shreveport, Louisiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center, Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina/Hollings Cancer Center, Charleston, South Carolina, United States
Saint Francis Hospital / Bon Secours, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Brooke Army Medical Center, San Antonio, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Intermountain Blood and Marrow Transplant/Acute Leukemia Program, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, , Australia
Monash Medical Centre, Clayton, , Australia
St George Hospital, Kogarah, , Australia
Royal Perth Hospital, Perth, , Australia
Sunshine Hospital, St Albans, , Australia
LKH Salzburg, Universitatsklinikum der PMU, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Ziekenhuis Netwerk Antwerpen Campus Stuivenberg, Antwerpen, , Belgium
Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan, Brugge, , Belgium
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Centre Hospitalier Universitaire Sart Tilman Liege, Liege, , Belgium
AZ Delta - Campus Wilgenstraat, Roeselare, , Belgium
Cliniques Universitaires UCL de Mont-Goddine, Yvoir, , Belgium
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava, Ostrava - Poruba, , Czechia
Ustav hematologie a krevni transfuze, Praha 2, , Czechia
CHU Amiens Picardie - Site Sud, Amiens Cedex 1, , France
Center Hospitalier Universitaire d' Angers, Angers Cedex 9, , France
Centre Hospitalier Victor Dupouy d'Argenteuil, Argenteuil Cedex, , France
Centre Hospitalier Universitaire Hopital Avicenne, Bobigny Cedex, , France
Hopital d'Instruction des Armees - Percy, Clamart Cedex, , France
CHRU de Lille, Lille cedex, , France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren, Limoges Cedex, , France
Hopital Emile Muller, Mulhouse Cedex, , France
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Nantes cedex 1, , France
CHU de Nice - Hopital l'Archet, Nice, , France
Hopital Saint-Louis / Service d'Hematologie, Paris Cedex 10, , France
CHU Bordeaux Hopital Haut-Levaque, Pessac Cedex, , France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers Cedex, , France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou, Rennes Cedex 9, , France
Stadtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Marien Hospital Dusseldorf GmbH, Dusseldorf, , Germany
Universitatsklinik Freiburg, Freiburg, , Germany
Universitatsklinikum Schleswig-Holstein, Kiel, , Germany
Universitatsklinikum Koln, Köln, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika, Debrecen, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza, Kecskemet, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont, Szeged, , Hungary
Barzilai Medical Center, Ashkelon, , Israel
Soroka Medical Center, Dept. of Oncology, Beer Sheva, , Israel
Carmel Medical Center, Haifa, , Israel
Edith Wolfson Medical Center, Holon, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I, Roma, , Italy
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Chonbuk National University Hospital, Jeonju-si, , Korea, Republic of
Seoul National University Hospital, Jongno-gu, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Centre Hospitalier Luxembourg - CHL Centre, Luxembourg, , Luxembourg
SPZOZ Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Warszawa, , Poland
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Hospital de la Santa Creu i Sant Paul, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital San Pedro de Alcantara, Caceres, , Spain
Hospital Universitario de Girona Doctor Josep Trueta, Girona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitaro de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
National Cheng-Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
County Durham and Darlington NHS Foundation Trust, Darlington, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
North West London Hospitals NHS Trust, Middlesex, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
University Hospitals of North Midlands NHS Trust, Stoke on Trent, , United Kingdom
Contact Details
Name: Phoenix Ho, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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