The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
750 mg/m2 IV every 3 weeks (Cycles 3-8)
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
750 mg/m2 IV every 3 weeks (Cycles 1-6)
50 mg/m2 IV every 3 weeks (Cycles 3-8)
50 mg/m2 IV every 3 weeks (Cycles 1-6)
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
St. Francis Hospital
Greenville, South Carolina, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom
...and 1 more locations
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
Progression-free survival
Time frame: Until disease progression or study closure
Overall survival
Time frame: Every 3 months until death or study closure
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