Data from Clinical Trials - Curated by EPG Health - Last updated 16 August 2017

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine extends overall survival longer than placebo combined with either azacitidine or decitabine.

purpose

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine extends overall survival longer than placebo combined with either azacitidine or decitabine.

Primary Outcome Measures:

  • Overall survival [ Time Frame: Up to approximately 5 years ]

Secondary Outcome Measures:

  • Composite complete remission rate [ Time Frame: Through 1 month following last dose ]
  • Event-free survival [ Time Frame: Up to approximately 5 years ]
  • Leukemia-free survival [ Time Frame: Up to approximately 5 years ]
  • Duration of remission [ Time Frame: Up to approximately 5 years ]
  • Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  • Laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  • Time to response [ Time Frame: Through 1 month following last dose ]
  • Mortality rates at Day 30 and Day 60 post the first study treatment [ Time Frame: Day 30 and Day 60 following the first dose ]
  • Minimal residual disease (MRD) status [ Time Frame: Up to approximately 5 years ]
Category Value
Date last updated at source 30-Mar-17
Recruiting in France, Taiwan, Australia, Hungary, Belgium, Italy, Spain, Czech Republic, Austria, Poland, Republic of Korea, United Kingdom, Israel, United States of America, Germany
Study type(s) Interventional
Expected enrolment 500
Study start date 01-May-16
Estimated primary completion date 01-Sep-19

View full details

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

CDK 4/6 inhibitors in metastatic breast cancer

CDK 4/6 inhibitors in metastatic breast cancer

The CDK 4/6 Inhibitors in Metastatic Breast Cancer Learning Zone provides insights and information for metastatic breast cancer (mBC) and CDK 4/6 signalling. This includes the burden and pathophysiology of the disease, the role of CDK 4/6 in cell proliferation and an overview of the CDK 4/6 inhibitors that have been approved for the management of mBC.

Cushing's Syndrome

Cushing's Syndrome

Cushing’s syndrome shares symptoms such as hypertension, glucose intolerance and obesity with other common conditions – how can you confidently diagnose this rare disorder?

+ 2 more

Load more

Related Content