A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

Completed · Phase 1

Conditions studied: Disease, Hodgkin

In brief

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.

Key facts

Study ID

NCT01060904

Run by

Seagen Inc.

People needed

51

Starts

2010-01-01

Expected to finish

2012-09-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
• Measurable disease of at least 1.5 cm
• Eastern Cooperative Oncology Group performance status <3

You may not qualify if…

• History of another primary malignancy that has not been in remission for at least 3 years
• Known cerebral/meningeal disease

Where it is running

• 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

Full record on ClinicalTrials.gov

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