Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Biomarker/Laboratory analysis, Treatment | Completed | 18 to 60 | Pharmaceutical / Industry | SGN35-009 NCT01060904 |
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.
Eligibility Criteria
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
Trial Lead Organizations/Sponsors
Seattle Genetics, Incorporated
Millennium Pharmaceuticals, Incorporated| Naomi Hunder, MD |  | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01060904
Information obtained from ClinicalTrials.gov on November 20, 2012
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