search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
33A
placebo
azacitidine
decitabine
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Antibodies, monoclonal, Antibody drug conjugate, Antigens, cluster of differentiation 33 (CD33), Drug therapy, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University of Arkansas for Medical Sciences
  • City of Hope National Medical Center
  • Pacific Hematology Oncology Associates
  • Colorado Blood Cancer Institute
  • Florida Cancer Specialists - South Region
  • Shands Cancer Center / University of Florida
  • Memorial Cancer Institute
  • Florida Center for Cellular Therapy / Blood and Marrow Transplant Center
  • Florida Cancer Specialists - North Region
  • Northside Hospital
  • OnCare Hawaii
  • Rush University Medical Center
  • University of Chicago
  • University of Kansas Cancer Center
  • Norton Cancer Institute
  • LSU Health Sciences Center / Feist Weiller Cancer Center
  • Center for Cancer and Blood Disorders
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • Roswell Park Cancer Institute
  • James P. Wilmot Cancer Center / University of Rochester Medical Center
  • Duke University Medical Center
  • Providence Portland Medical Center
  • University of Pennsylvania
  • Rhode Island Hospital
  • Medical University of South Carolina/Hollings Cancer Center
  • Saint Francis Hospital / Bon Secours
  • Sarah Cannon Research Institute
  • MD Anderson Cancer Center / University of Texas
  • Brooke Army Medical Center
  • Texas Oncology - San Antonio Medical Center
  • Intermountain Blood and Marrow Transplant/Acute Leukemia Program
  • University of Virginia
  • Virginia Commonwealth University Medical Center
  • Swedish Cancer Institute
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • St George Hospital
  • Royal Perth Hospital
  • Sunshine Hospital
  • LKH Salzburg, Universitatsklinikum der PMU
  • Klinikum Wels-Grieskirchen GmbH
  • Ziekenhuis Netwerk Antwerpen Campus Stuivenberg
  • Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan
  • Cliniques Universitaires Saint Luc
  • Institut Jules Bordet
  • Centre Hospitalier Universitaire Sart Tilman Liege
  • AZ Delta - Campus Wilgenstraat
  • Cliniques Universitaires UCL de Mont-Goddine
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
  • Fakultni Nemocnice Ostrava
  • Ustav hematologie a krevni transfuze
  • CHU Amiens Picardie - Site Sud
  • Center Hospitalier Universitaire d' Angers
  • Centre Hospitalier Victor Dupouy d'Argenteuil
  • Centre Hospitalier Universitaire Hopital Avicenne
  • Hopital d'Instruction des Armees - Percy
  • CHRU de Lille
  • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
  • Hopital Emile Muller
  • Centre Hospitalier Universitaire Nantes-Hotel Dieu
  • CHU de Nice - Hopital l'Archet
  • Hopital Saint-Louis / Service d'Hematologie
  • CHU Bordeaux Hopital Haut-Levaque
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
  • Stadtisches Klinikum Braunschweig gGmbH
  • Marien Hospital Dusseldorf GmbH
  • Universitatsklinik Freiburg
  • Universitatsklinikum Schleswig-Holstein
  • Universitatsklinikum Koln
  • Semmelweis Egyetem
  • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
  • Barzilai Medical Center
  • Soroka Medical Center, Dept. of Oncology
  • Carmel Medical Center
  • Edith Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center
  • Tel Aviv Sourasky Medical Center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medical Center
  • Chungnam National University Hospital
  • Chonnam National University Hwasun Hospital
  • Chonbuk National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Seoul Saint Mary's Hospital
  • Korea University Guro Hospital
  • Centre Hospitalier Luxembourg - CHL Centre
  • SPZOZ Szpital Uniwersytecki w Krakowie
  • Samodzielny Publiczny Centralny Szpital Kliniczny
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de la Santa Creu i Sant Paul
  • Hospital Universitario Vall d'Hebron
  • Hospital San Pedro de Alcantara
  • Hospital Universitario de Girona Doctor Josep Trueta
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitaro de Salamanca
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Changhua Christian Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • County Durham and Darlington NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • North West London Hospitals NHS Trust
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust
  • University Hospitals of North Midlands NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

33A + HMA

placebo + HMA

Arm Description

33A plus azacitidine or decitabine

placebo plus azacitidine or decitabine

Outcomes

Primary Outcome Measures

Overall Survival
Time from randomization to death due to any cause
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.

Secondary Outcome Measures

Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate
Number of patients who achieve both remission (CR or CRi) and MRD-negative status
Duration of Remission
Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Event-free Survival
Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.
Leukemia-free Survival
Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.
Incidence of Grade 3 or Higher Laboratory Abnormalities
Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)
Time to Complete Remission
Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
Mortality Rates at Day 30 and Day 60
30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.

Full Information

First Posted
May 25, 2016
Last Updated
November 21, 2018
Sponsor
Seagen Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02785900
Brief Title
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Acronym
CASCADE
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to safety; specifically a higher rate of deaths, including fatal infections, in the SGN33A arm versus the control arm
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Antibodies, monoclonal, Antibody drug conjugate, Antigens, cluster of differentiation 33 (CD33), Drug therapy, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
33A + HMA
Arm Type
Experimental
Arm Description
33A plus azacitidine or decitabine
Arm Title
placebo + HMA
Arm Type
Active Comparator
Arm Description
placebo plus azacitidine or decitabine
Intervention Type
Drug
Intervention Name(s)
33A
Other Intervention Name(s)
vadastuximab talirine, SGN-CD33A
Intervention Description
33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
Intervention Type
Drug
Intervention Name(s)
azacitidine
Intervention Description
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
Intervention Type
Drug
Intervention Name(s)
decitabine
Intervention Description
20 mg/m2 given IV x 5 days, every 4 weeks
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization to death due to any cause
Time Frame
Up to 1.5 years
Title
Composite Complete Remission (CRc) Rate
Description
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.
Time Frame
Up to 1.5 years
Secondary Outcome Measure Information:
Title
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate
Description
Number of patients who achieve both remission (CR or CRi) and MRD-negative status
Time Frame
Up to 1.5 years
Title
Duration of Remission
Description
Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Time Frame
Up to approximately 9.5 months
Title
Event-free Survival
Description
Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.
Time Frame
Up to approximately 11.24 months
Title
Leukemia-free Survival
Description
Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Time Frame
Up to approximately 9.49 months
Title
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events
Description
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.
Time Frame
Up to 1.5 years
Title
Incidence of Grade 3 or Higher Laboratory Abnormalities
Description
Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)
Time Frame
Up to 1.5 years
Title
Time to Complete Remission
Description
Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
Time Frame
Up to 1.5 years
Title
Mortality Rates at Day 30 and Day 60
Description
30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phoenix Ho, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Florida Cancer Specialists - South Region
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Shands Cancer Center / University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Florida Center for Cellular Therapy / Blood and Marrow Transplant Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Florida Cancer Specialists - North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
OnCare Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
United States
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center / Feist Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
James P. Wilmot Cancer Center / University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina/Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Saint Francis Hospital / Bon Secours
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
30384
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234-7679
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Intermountain Blood and Marrow Transplant/Acute Leukemia Program
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
St George Hospital
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
ZIP/Postal Code
3021
Country
Australia
Facility Name
LKH Salzburg, Universitatsklinikum der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen Campus Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Sart Tilman Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta - Campus Wilgenstraat
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Goddine
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Ustav hematologie a krevni transfuze
City
Praha 2
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
CHU Amiens Picardie - Site Sud
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Center Hospitalier Universitaire d' Angers
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier Victor Dupouy d'Argenteuil
City
Argenteuil Cedex
ZIP/Postal Code
95107
Country
France
Facility Name
Centre Hospitalier Universitaire Hopital Avicenne
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital d'Instruction des Armees - Percy
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
CHRU de Lille
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Emile Muller
City
Mulhouse Cedex
ZIP/Postal Code
68070
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes-Hotel Dieu
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice - Hopital l'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Saint-Louis / Service d'Hematologie
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Bordeaux Hopital Haut-Levaque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Stadtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Marien Hospital Dusseldorf GmbH
City
Dusseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universitatsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka Medical Center, Dept. of Oncology
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49414
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju-si
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Centre Hospitalier Luxembourg - CHL Centre
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
SPZOZ Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Paul
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10002
Country
Spain
Facility Name
Hospital Universitario de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitaro de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
County Durham and Darlington NHS Foundation Trust
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
North West London Hospitals NHS Trust
City
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs