Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT02785900
Last Updated: 2018-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
240 participants
INTERVENTIONAL
2016-05-31
2017-10-03
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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33A + HMA
33A plus azacitidine or decitabine
33A
33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
placebo + HMA
placebo plus azacitidine or decitabine
placebo
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
Interventions
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33A
33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
placebo
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intermediate or adverse cytogenetic risk
* Eligible for therapy with either decitabine or azacitidine
* Acceptable hematologic and organ function
Exclusion Criteria
* Patients who are candidates for allogeneic stem cell transplant at the time of enrollment
* Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
* Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phoenix Ho, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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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
St. 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
St 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
Antwerp, , Belgium
Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Centre Hospitalier Universitaire Sart Tilman Liege
Liège, , 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 Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, , Czechia
Ustav hematologie a krevni transfuze
Prague, , Czechia
CHU Amiens Picardie - Site Sud
Amiens, , France
Center Hospitalier Universitaire d' Angers
Angers, , France
Centre Hospitalier Victor Dupouy d'Argenteuil
Argenteuil, , France
Centre Hospitalier Universitaire Hopital Avicenne
Bobigny, , France
Hopital d'Instruction des Armees - Percy
Clamart, , France
CHRU de Lille
Lille, , France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
Limoges, , France
Hopital Emile Muller
Mulhouse, , France
Centre Hospitalier Universitaire Nantes-Hotel Dieu
Nantes, , France
CHU de Nice - Hopital l'Archet
Nice, , France
Hopital Saint-Louis / Service d'Hematologie
Paris, , France
CHU Bordeaux Hopital Haut-Levaque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
Rennes, , France
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Marien Hospital Dusseldorf GmbH
Düsseldorf, , Germany
Universitatsklinik Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , 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
Kecskemét, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center, Dept. of Oncology
Beersheba, , 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
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , 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
Centre Hospitalier Luxembourg - CHL Centre
Luxembourg, , Luxembourg
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Hospital
Jongno-gu, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
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
Cáceres, , Spain
Hospital Universitario de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , 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 City, , 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
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2015-003482-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SGN33A-005
Identifier Type: -
Identifier Source: org_study_id