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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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)
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Secondary ID [1]
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2015-003482-28
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Secondary ID [2]
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SGN33A-005
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Universal Trial Number (UTN)
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Trial acronym
CASCADE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Time from randomization to death due to any cause
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Timepoint [1]
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Up to 1.5 years
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Primary outcome [2]
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Composite Complete Remission (CRc) Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 1.5 years
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Secondary outcome [1]
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Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate
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Assessment method [1]
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Number of patients who achieve both remission (CR or CRi) and MRD-negative status
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Timepoint [1]
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Up to 1.5 years
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Secondary outcome [2]
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Duration of Remission
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 9.5 months
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Secondary outcome [3]
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Event-free Survival
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 11.24 months
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Secondary outcome [4]
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Leukemia-free Survival
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 9.49 months
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Secondary outcome [5]
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Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 1.5 years
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Secondary outcome [6]
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Incidence of Grade 3 or Higher Laboratory Abnormalities
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Assessment method [6]
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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)
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Timepoint [6]
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Up to 1.5 years
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Secondary outcome [7]
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Time to Complete Remission
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Assessment method [7]
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Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
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Timepoint [7]
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Up to 1.5 years
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Secondary outcome [8]
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Mortality Rates at Day 30 and Day 60
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Assessment method [8]
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30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.
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Timepoint [8]
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Up to 60 days
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/10/2017
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Sample size
Target
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Monash Medical Centre - Clayton
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St George Hospital - Kogarah
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Royal Perth Hospital - Perth
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Sunshine Hospital - St Albans
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5000 - Adelaide
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3168 - Clayton
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2217 - Kogarah
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6000 - Perth
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3021 - St Albans
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Stoke on Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Seagen Inc.
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02785900
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Phoenix Ho, MD
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Address
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Seagen Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02785900
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