A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
Phase 1
Completed
- Conditions
- Disease, Hodgkin
- Interventions
- Registration Number
- NCT01060904
- Lead Sponsor
- Seagen Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group performance status <3
Exclusion Criteria
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 vinblastine brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) 2 brentuximab vedotin brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) 1 brentuximab vedotin brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) 1 doxorubicin brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) 1 vinblastine brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) 1 dacarbazine brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) 2 doxorubicin brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) 2 dacarbazine brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) 1 bleomycin brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
- Primary Outcome Measures
Name Time Method Incidence of adverse events and laboratory abnormalities Through 1 month after last dose
- Secondary Outcome Measures
Name Time Method Brentuximab vedotin concentration in blood Through 1 month after last dose Antitherapeutic antibodies in blood Through 1 month after last dose Best clinical response Through 1 month after last dose
Trial Locations
- Locations (4)
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
British Columbia Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada