Study Title
A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma (NCT01060904)
Trial Description
The purpose of this study is to assess the safety profile of the antibody-drug conjugate brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma (HL). It is a phase I, 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.
This trial is sponsored by Millennium Pharmaceuticals/Seattle Genetics.
Study Data
- Condition: Hodgkin Lymphoma
- Interventions:
- Drugs used in this trial
- Brentuximab vedotin (Adcetris®; Seattle Genetics, Inc.)
- Doxorubicin (Doxil®; TTY Bio pharmacy Company Limited)
- Bleomycin (Generic; Teva Parenteral Medicines, Inc.)
- Vinblastine (Generic; APP Pharmaceuticals, LLC)
- Dacarbazine (DTIC-Dome®; Bayer Pharmaceuticals Corporation)
- Drugs used in this trial
- Phase: I
- Enrollment: 51
- Start: January 2010
- Completion: September 2012
- Last verified: December 2014
Study Schematic
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Last Editorial review: July 15, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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