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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Time from randomization to death due to any cause
Timepoint [1] 0 0
Up to 1.5 years
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 1.5 years
Secondary outcome [1] 0 0
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate - Number of patients who achieve both remission (CR or CRi) and MRD-negative status
Timepoint [1] 0 0
Up to 1.5 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to approximately 9.5 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to approximately 11.24 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to approximately 9.49 months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to 1.5 years
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Up to 1.5 years
Secondary outcome [7] 0 0
Time to Complete Remission - Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
Timepoint [7] 0 0
Up to 1.5 years
Secondary outcome [8] 0 0
Mortality Rates at Day 30 and Day 60 - 30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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United States of America
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Hawaii
Country [7] 0 0
United States of America
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Illinois
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United States of America
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New York
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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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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Austria
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Salzburg
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Austria
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Wels
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Belgium
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Antwerpen
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Belgium
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Brugge
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Brussels
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Bruxelles
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Liege
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Roeselare
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Yvoir
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Brno
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Hradec Kralove
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Czechia
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Ostrava - Poruba
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Czechia
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Praha 2
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France
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Amiens Cedex 1
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Angers Cedex 9
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Argenteuil Cedex
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Bobigny Cedex
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Clamart Cedex
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Lille cedex
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Nantes cedex 1
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Paris Cedex 10
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Pierre Bénite Cedex
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Rennes Cedex 9
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Dusseldorf
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Freiburg
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Köln
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Debrecen
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Kaposvár
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Kecskemet
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Szeged
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Ashkelon
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Beer Sheva
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Haifa
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Holon
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Jerusalem
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Petach Tikva
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Tel Aviv
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Daejeon
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Hwasun
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Krakow
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Badalona
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Barcelona
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Girona
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Malaga
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Salamanca
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Valencia
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Changhua
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Darlington
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London
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Middlesex
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Newcastle Upon Tyne
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Southampton
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United Kingdom
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Stoke on Trent

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02785900
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02785900