The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
0.6-1.2 mg/kg IV every 2 weeks
25 mg/m2 IV every 2 weeks
6 mg/m2 IV every 2 weeks
Mayo Clinic
Rochester, Minnesota, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month after last dose
Brentuximab vedotin concentration in blood
Time frame: Through 1 month after last dose
Antitherapeutic antibodies in blood
Time frame: Through 1 month after last dose
Best clinical response
Time frame: Through 1 month after last dose
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375 mg/m2 IV every 2 weeks
10 units/m2 IV every 2 weeks
0.9-1.2 mg/kg IV every 2 weeks