CASCADE TRIAL :
Currently Enrolling Patients With Acute Myeloid Leukemia
Vadastuximab Talirine ( SGN-CD33A ) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia ( CASCADE )
Study Description
A phase 3 , randomized , double-blind study of vadastuximab talirine ( SGN-CD33A ) in combination with azacitidine or decitabine versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia .
Study Schema
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Stratification Factors for Randomization
• Cytogenetic risk
• ECOG
• HMA
• Age
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1:1
A N D O M I Z A T I O N
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Vadastuximab talirine + HMA in 4-week cycles
Placebo + HMA in 4-week cycles
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Primary End Point :
Overall survivalR
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ECOG , Eastern Cooperative Oncology Group ; HMA , hypomethylating agent .
Follow-up : For patients who discontinue treatment prior to progression or leukemic recurrence , response assessments continue every 2 months through 24 months . For all patients , survival status follow-up is every 2 months .
Mechanism of Action
Vadastuximab talirine ( SGN-CD33A ) is a highly potent , engineered antibody-drug conjugate ( ADC ) designed to deliver a cytotoxic agent to CD33-expressing malignant myeloid cells .
Study Location
North America | Europe | South Korea | Taiwan | Israel | Australia
Please call 866-333-7436 if you have a patient who may qualify for the CASCADE trial . For additional information on this study , visit www . clinicaltrials . gov , identifier : NCT02785900 . Go to www . adc-cd33 . com to learn more about ADC technology .
Vadastuximab talirine is an investigational agent , and its safety and efficacy have not been established .
© 2016 Seattle Genetics , Inc . All rights reserved . USM / 33A / 2016 / 0009 10 / 16