This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)
Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
417
Abelacimab 150 mg
Dalteparin 200 IU/kg/day followed by 150 IU/kg/day
Time to first event of centrally adjudicated VTE recurrence
Time to first adjudicated venous thromboembolism (VTE) event recurrence
Time frame: up to 6 months
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events
Time to first adjudicated major or clinically relevant non-major (CRNM) bleeding event
Time frame: up to 6 months
Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated CRNM bleeding events
Time to first adjudicated venous thromboembolism (VTE) or bleeding event
Time frame: up to 6 months
Time to event of permanent treatment discontinuation not due to death
Time to permanent discontinuation not due to death
Time frame: up to 6 months
Time to first event of ISTH-adjudicated CRNM bleeding events
Time to first adjudicated clinically relevant non-major (CRNM) bleeding event
Time frame: up to 6 months
Time to first event of ISTH-adjudicated major bleeding events
Time to first adjudicated major bleeding event
Time frame: Up to 6 months
Time to first event of GI ISTH-adjudicated major and GI CRNM bleeding events
Time to first adjudicated gastrointestinal (GI) major and clinically relevant non-major (CRNM) bleeding event
Time frame: up to 6 months
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Washington DC VAMC
Washington D.C., District of Columbia, United States
NorthShore University Health System
Evanston, Illinois, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Middletown
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center-Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center-West Harrison
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
...and 107 more locations
All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient-years
Time frame: up to 6 months
For patients treated with abelacimab: percent with injection site reactions/severity, hypersensitivity reactions/severity, anti-drug antibody formation, neutralizing antibody
Time frame: up to 6 months