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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentCompleted18 to 60Pharmaceutical / IndustrySGN35-009

Trial Description


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 Contact Information

Trial Lead Organizations/Sponsors

Seattle Genetics, Incorporated

  • Millennium Pharmaceuticals, Incorporated
Naomi Hunder, MD, Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01060904
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.