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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02785900




Registration number
NCT02785900
Ethics application status
Date submitted
25/05/2016
Date registered
30/05/2016
Date last updated
12/12/2018

Titles & IDs
Public title
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Scientific 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)
Secondary ID [1] 0 0
2015-003482-28
Secondary ID [2] 0 0
SGN33A-005
Universal Trial Number (UTN)
Trial acronym
CASCADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 33A
Treatment: Drugs - placebo
Treatment: Drugs - azacitidine
Treatment: Drugs - decitabine

Experimental: 33A + HMA - 33A plus azacitidine or decitabine

Active comparator: placebo + HMA - placebo plus azacitidine or decitabine


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

Treatment: Drugs: placebo
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push

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

Treatment: Drugs: decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 1.5 years
Primary outcome [2] 0 0
Composite Complete Remission (CRc) Rate
Timepoint [2] 0 0
Up to 1.5 years
Secondary outcome [1] 0 0
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate
Timepoint [1] 0 0
Up to 1.5 years
Secondary outcome [2] 0 0
Duration of Remission
Timepoint [2] 0 0
Up to approximately 9.5 months
Secondary outcome [3] 0 0
Event-free Survival
Timepoint [3] 0 0
Up to approximately 11.24 months
Secondary outcome [4] 0 0
Leukemia-free Survival
Timepoint [4] 0 0
Up to approximately 9.49 months
Secondary outcome [5] 0 0
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events
Timepoint [5] 0 0
Up to 1.5 years
Secondary outcome [6] 0 0
Incidence of Grade 3 or Higher Laboratory Abnormalities
Timepoint [6] 0 0
Up to 1.5 years
Secondary outcome [7] 0 0
Time to Complete Remission
Timepoint [7] 0 0
Up to 1.5 years
Secondary outcome [8] 0 0
Mortality Rates at Day 30 and Day 60
Timepoint [8] 0 0
Up to 60 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2017
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
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United States of America
State/province [11] 0 0
Maryland
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United States of America
State/province [12] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
State/province [16] 0 0
New York
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United States of America
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North Carolina
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Oregon
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
Country [23] 0 0
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Texas
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United States of America
State/province [24] 0 0
Utah
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United States of America
State/province [25] 0 0
Virginia
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United States of America
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Washington
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Austria
State/province [27] 0 0
Salzburg
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Austria
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Wels
Country [29] 0 0
Belgium
State/province [29] 0 0
Antwerpen
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Belgium
State/province [30] 0 0
Brugge
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussels
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Belgium
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Bruxelles
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Belgium
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Liege
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Belgium
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Roeselare
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Belgium
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Yvoir
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Czechia
State/province [36] 0 0
Brno
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Czechia
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Hradec Kralove
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Czechia
State/province [38] 0 0
Ostrava - Poruba
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 2
Country [40] 0 0
France
State/province [40] 0 0
Amiens Cedex 1
Country [41] 0 0
France
State/province [41] 0 0
Angers Cedex 9
Country [42] 0 0
France
State/province [42] 0 0
Argenteuil Cedex
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France
State/province [43] 0 0
Bobigny Cedex
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France
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Clamart Cedex
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France
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Lille cedex
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France
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Limoges Cedex
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France
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Mulhouse Cedex
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France
State/province [48] 0 0
Nantes cedex 1
Country [49] 0 0
France
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Nice
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France
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Paris Cedex 10
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France
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Pessac Cedex
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France
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Pierre Bénite Cedex
Country [53] 0 0
France
State/province [53] 0 0
Poitiers Cedex
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France
State/province [54] 0 0
Rennes Cedex 9
Country [55] 0 0
Germany
State/province [55] 0 0
Braunschweig
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Germany
State/province [56] 0 0
Dusseldorf
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Germany
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Freiburg
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Germany
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Kiel
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Germany
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Köln
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
State/province [62] 0 0
Kaposvár
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Hungary
State/province [63] 0 0
Kecskemet
Country [64] 0 0
Hungary
State/province [64] 0 0
Szeged
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [68] 0 0
Holon
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Israel
State/province [69] 0 0
Jerusalem
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Israel
State/province [70] 0 0
Petach Tikva
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Israel
State/province [71] 0 0
Tel Aviv
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Italy
State/province [72] 0 0
Milano
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Italy
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Orbassano
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Italy
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Pesaro
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Italy
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Roma
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Jeonju-si
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Korea, Republic of
State/province [80] 0 0
Jongno-gu
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Korea, Republic of
State/province [81] 0 0
Seoul
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Luxembourg
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Luxembourg
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Poland
State/province [83] 0 0
Krakow
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Poland
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Warszawa
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Spain
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Badalona
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
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Caceres
Country [88] 0 0
Spain
State/province [88] 0 0
Girona
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Malaga
Country [91] 0 0
Spain
State/province [91] 0 0
Salamanca
Country [92] 0 0
Spain
State/province [92] 0 0
Valencia
Country [93] 0 0
Taiwan
State/province [93] 0 0
Changhua
Country [94] 0 0
Taiwan
State/province [94] 0 0
Tainan
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Darlington
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Middlesex
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Newcastle Upon Tyne
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Southampton
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Phoenix Ho, MD
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02785900