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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
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United States of America
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Arkansas
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California
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Illinois
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Taipei
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Darlington
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Newcastle Upon Tyne
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Southampton
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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/study/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/study/NCT02785900