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)
Status: Terminated
Location: See all (124) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
• Intermediate or adverse cytogenetic risk
• Eligible for therapy with either decitabine or azacitidine
• Acceptable hematologic and organ function
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
California
City of Hope National Medical Center
Duarte
Pacific Hematology Oncology Associates
San Francisco
Colorado
Colorado Blood Cancer Institute
Denver
Florida
Florida Cancer Specialists - South Region
Fort Myers
Shands Cancer Center / University of Florida
Gainesville
Memorial Cancer Institute
Miami
Florida Center for Cellular Therapy / Blood and Marrow Transplant Center
Orlando
Florida Cancer Specialists - North Region
Saint Petersburg
Georgia
Northside Hospital
Atlanta
Hawaii
OnCare Hawaii
Honolulu
Illinois
Rush University Medical Center
Chicago
University of Chicago
Chicago
Kansas
University of Kansas Cancer Center
Westwood
Kentucky
Norton Cancer Institute
Louisville
Louisiana
LSU Health Sciences Center / Feist Weiller Cancer Center
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
Center for Cancer and Blood Disorders
Bethesda
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Missouri
Washington University School of Medicine
Saint Louis
North Carolina
Duke University Medical Center
Durham
New Jersey
Hackensack University Medical Center
Hackensack
New York
Roswell Park Cancer Institute
Buffalo
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester
Oregon
Providence Portland Medical Center
Portland
Pennsylvania
University of Pennsylvania
Philadelphia
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina/Hollings Cancer Center
Charleston
Saint Francis Hospital / Bon Secours
Greenville
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
MD Anderson Cancer Center / University of Texas
Houston
Brooke Army Medical Center
San Antonio
Texas Oncology - San Antonio Medical Center
San Antonio
Utah
Intermountain Blood and Marrow Transplant/Acute Leukemia Program
Salt Lake City
Virginia
University of Virginia
Charlottesville
Virginia Commonwealth University Medical Center
Richmond
Washington
Swedish Cancer Institute
Seattle
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Monash Medical Centre
Clayton
St George Hospital
Kogarah
Royal Perth Hospital
Perth
Sunshine Hospital
St Albans
Austria
LKH Salzburg, Universitatsklinikum der PMU
Salzburg
Klinikum Wels-Grieskirchen GmbH
Wels
Belgium
Ziekenhuis Netwerk Antwerpen Campus Stuivenberg
Antwerpen
Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan
Brugge
Cliniques Universitaires Saint Luc
Brussels
Institut Jules Bordet
Bruxelles
Centre Hospitalier Universitaire Sart Tilman Liege
Liege
AZ Delta - Campus Wilgenstraat
Roeselare
Cliniques Universitaires UCL de Mont-Goddine
Yvoir
France
CHU Amiens Picardie - Site Sud
Amiens Cedex 1
Center Hospitalier Universitaire d' Angers
Angers Cedex 9
Centre Hospitalier Victor Dupouy d'Argenteuil
Argenteuil Cedex
Centre Hospitalier Universitaire Hopital Avicenne
Bobigny Cedex
Hopital d'Instruction des Armees - Percy
Clamart Cedex
CHRU de Lille
Lille Cedex
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
Limoges Cedex
Hopital Emile Muller
Mulhouse Cedex
Centre Hospitalier Universitaire Nantes-Hotel Dieu
Nantes Cedex 1
CHU de Nice - Hopital l'Archet
Nice
Hopital Saint-Louis / Service d'Hematologie
Paris Cedex 10
CHU Bordeaux Hopital Haut-Levaque
Pessac Cedex
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex
Centre Hospitalier Universitaire de Poitiers
Poitiers Cedex
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
Rennes Cedex 9
Germany
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig
Marien Hospital Dusseldorf GmbH
Dusseldorf
Universitatsklinik Freiburg
Freiburg
Universitatsklinikum Schleswig-Holstein
Kiel
Universitatsklinikum Koln
Köln
Hungary
Semmelweis Egyetem
Budapest
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
Kecskemet
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged
Israel
Barzilai Medical Center
Ashkelon
Soroka Medical Center, Dept. of Oncology
Beer Sheva
Carmel Medical Center
Haifa
Edith Wolfson Medical Center
Holon
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petach Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano
IRCCS Ospedale San Raffaele
Milano
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
Orbassano
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro
Università degli Studi di Roma La Sapienza, Policlinico Umberto I
Roma
Luxembourg
Centre Hospitalier Luxembourg - CHL Centre
Luxembourg
Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa
Republic of Korea
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Chonnam National University Hwasun Hospital
Hwasun
Chonbuk National University Hospital
Jeonju-si
Seoul National University Hospital
Jongno-gu
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Saint Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Spain
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital de la Santa Creu i Sant Paul
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital San Pedro de Alcantara
Caceres
Hospital Universitario de Girona Doctor Josep Trueta
Girona
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Virgen de la Victoria
Malaga
Hospital Universitaro de Salamanca
Salamanca
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Taiwan
Changhua Christian Hospital
Changhua
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington
Imperial College Healthcare NHS Trust
London
North West London Hospitals NHS Trust
Middlesex
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
University Hospital Southampton NHS Foundation Trust
Southampton
University Hospitals of North Midlands NHS Trust
Stoke On Trent
Time Frame
Start Date: 2016-05
Completion Date: 2017-10-03
Participants
Target number of participants: 240
Treatments
Experimental: 33A + HMA
33A plus azacitidine or decitabine
Active_comparator: placebo + HMA
placebo plus azacitidine or decitabine
Authors
Sigrid Cherrier - de Wilde, Farhad Ravandi-Kashani, James Reeves, Don Stevens, Selina Luger, Jane Liesveld, John Reagan, Eunice Wang, Dale Bixby, Caroline Behler, Howland Crosswell, Michael Keng, Maxim Norkin, Min Kyoung Kim, Robert Stuart, Jon Fukumoto, Raya Mawad, Jennifer Cultrera, Roger Lyons, Nicki Panoskaltsis, Ralph Boccia, Yehuda Deutsch, Asad Bashey, John Godwin, Rushang Patel, Yogesh Jethava, Anthony Stein, Jamie Koprivnikar, Tara Lin, Russell Baur, Amir Fathi, Michael Maris, Nebu Koshy, Camille Abboud, Mario Ojeda-Uribe, Berengere Gruson, Pascal Turlure, Bruno Quesnel, Karl-Anton Kreuzer, Thorsten Braun, Maria Pilar Gallego-Hernanz, Ahmad Al Jijakli, Patrice Chevallier, Jurgen Krauter, Michael Lubbert, Aristoteles Giagounidis, Arnaud Pigneux, Xavier Thomas, Marc Bernard, Lionel Ades, Thomas Cluzeau, Daanish Hoda, William Donnellan, Kellie Sprague, Agostino Cortelezzi, Roberto Foa, Aleksander Skotnicki, Heinz-August Horst, Yoo Hong Min, Ian Lewis, Young Rok Do, Zita Borbenyi, Giuseppe Visani, Eduardo Olavarria, Jae-Yong Kwak, Ronit Gurion, Tsai-Yun Chen, Jadwiga Dwilewicz-Trojaczek, Violaine Havelange, Michael Leahy, Sebastian Wittnebel, Dries Deeren, Judit Demeter, Dimitri Breems, Maria Belen Vidriales, Liang-Tsai Hsiao, Miklós Egyed, Sheng-Chieh Chou, Fabio Ciceri, Bernard De Prijck, Richard Greil, Carlos Graux, Cyril Salek, Olga Salamero, Ik-Chan Song, Jorge Sierra, Roman Hájek, Cheng-Shyong Chang, Susana Vives, Juan Miguel Bergua, Jake Shortt, Dominik Selleslag, Jean-Valere Malfuson, Pau Montesinos, Daniela Cilloni, Arpad Illes, Jiri Mayer, Mathilde Hunault
Related Therapeutic Areas
Sponsors
Leads: Seagen Inc.