Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02785900 | Terminated Phase 3 Results DMC

• 2 other identifiers: SGN33A-0052015-003482-28
• Study Type: interventional
• Target: 240
• Locations: 15 countries
• Sites: 126

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.

Conditions

Acute Myeloid Leukemia

Keywords

Antibodies, monoclonal; Antibody drug conjugate; Antigens, cluster of differentiation 33 (CD33); Drug therapy; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time from randomization to death due to any cause

  Up to 1.5 years

• Composite Complete Remission (CRc) Rate

  Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

  Up to 1.5 years

Secondary Outcomes (8)

• Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate

  Up to 1.5 years

• Duration of Remission

  Up to approximately 9.5 months

• Event-free Survival

  Up to approximately 11.24 months

• Leukemia-free Survival

  Up to approximately 9.49 months

• Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events

  Up to 1.5 years

Study Arms (2)

33A + HMA

EXPERIMENTAL

33A plus azacitidine or decitabine

Drug: 33A; Drug: azacitidine; Drug: decitabine

placebo + HMA

ACTIVE COMPARATOR

placebo plus azacitidine or decitabine

Drug: placebo; Drug: azacitidine; Drug: decitabine

Interventions

33A DRUG

33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push

Also known as: vadastuximab talirine, SGN-CD33A

33A + HMA

placebo DRUG

Volume equivalent to 10 mcg/kg, every 4 weeks via IV push

placebo + HMA

azacitidine DRUG

75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks

33A + HMA; placebo + HMA

decitabine DRUG

20 mg/m2 given IV x 5 days, every 4 weeks

33A + HMA; placebo + HMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)
• 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)

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (128)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists - South Region

Fort Myers, Florida, 33901, United States

Location

Shands Cancer Center / University of Florida

Gainesville, Florida, 32610, United States

Location

Memorial Cancer Institute

Miami, Florida, 33028, United States

Location

Florida Center for Cellular Therapy / Blood and Marrow Transplant Center

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists - North Region

St. Petersburg, Florida, 33705, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

OnCare Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, United States, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

LSU Health Sciences Center / Feist Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina/Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Saint Francis Hospital / Bon Secours

Greenville, South Carolina, 29601, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 30384, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234-7679, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

Intermountain Blood and Marrow Transplant/Acute Leukemia Program

Salt Lake City, Utah, 84143, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

St George Hospital

Kogarah, 2217, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Sunshine Hospital

St Albans, 3021, Australia

Location

LKH Salzburg, Universitatsklinikum der PMU

Salzburg, 5020, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

Antwerp, 2060, Belgium

Location

Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman Liege

Liège, 4000, Belgium

Location

AZ Delta - Campus Wilgenstraat

Roeselare, 8800, Belgium

Location

Cliniques Universitaires UCL de Mont-Goddine

Yvoir, 5530, Belgium

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Ustav hematologie a krevni transfuze

Prague, 128 20, Czechia

Location

CHU Amiens Picardie - Site Sud

Amiens, 80054, France

Location

Center Hospitalier Universitaire d' Angers

Angers, 49933, France

Location

Centre Hospitalier Victor Dupouy d'Argenteuil

Argenteuil, 95107, France

Location

Centre Hospitalier Universitaire Hopital Avicenne

Bobigny, 93009, France

Location

Hopital d'Instruction des Armees - Percy

Clamart, 92141, France

Location

CHRU de Lille

Lille, 59037, France

Location

Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

Limoges, 87042, France

Location

Hopital Emile Muller

Mulhouse, 68070, France

Location

Centre Hospitalier Universitaire Nantes-Hotel Dieu

Nantes, 44093, France

Location

CHU de Nice - Hopital l'Archet

Nice, 06200, France

Location

Hopital Saint-Louis / Service d'Hematologie

Paris, 75475, France

Location

CHU Bordeaux Hopital Haut-Levaque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

Rennes, 35033, France

Location

Stadtisches Klinikum Braunschweig gGmbH

Braunschweig, 38114, Germany

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

Marien Hospital Dusseldorf GmbH

Düsseldorf, 40479, Germany

Location

Universitatsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

Debrecen, 4004, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

Kecskemét, 6000, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

Szeged, 6720, Hungary

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Soroka Medical Center, Dept. of Oncology

Beersheba, 84101, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49414, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61100, Italy

Location

Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

Roma, 00161, Italy

Location

Centre Hospitalier Luxembourg - CHL Centre

Luxembourg, 1210, Luxembourg

Location

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-703, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 519-763, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Seoul National University Hospital

Jongno-gu, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul Saint Mary's Hospital

Seoul, 137-701, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Paul

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10002, Spain

Location

Hospital Universitario de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitaro de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

County Durham and Darlington NHS Foundation Trust

Darlington, DL3 6HX, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

North West London Hospitals NHS Trust

Middlesex, HA1 3UJ, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

vadastuximab talirine; Azacitidine; Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seattle Genetics, Inc.

medinfo@seagen.com

855-473-2436

Study Officials

• Phoenix Ho, MD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-11

Locations

CZ (4); IT (5); GB (6); PL (2); AU (5); ES (9); US (40); LU (1); DE (5); HU (5); FR (15); TW (4); IL (8); KR (10); BE (7)