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

December 17, 2014 updated by: Seagen Inc.

A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center / University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
Drug: brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
Other Names:
  • SGN-35
Drug: doxorubicin
25 mg/m2 IV every 2 weeks
Drug: vinblastine
6 mg/m2 IV every 2 weeks
Drug: dacarbazine
375 mg/m2 IV every 2 weeks
Drug: bleomycin
10 units/m2 IV every 2 weeks
Drug: brentuximab vedotin
0.9-1.2 mg/kg IV every 2 weeks
Other Names:
  • SGN-35
Experimental: 2
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
Drug: brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
Other Names:
  • SGN-35
Drug: doxorubicin
25 mg/m2 IV every 2 weeks
Drug: vinblastine
6 mg/m2 IV every 2 weeks
Drug: dacarbazine
375 mg/m2 IV every 2 weeks
Drug: brentuximab vedotin
0.9-1.2 mg/kg IV every 2 weeks
Other Names:
  • SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and laboratory abnormalities
Time Frame: Through 1 month after last dose
Through 1 month after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Brentuximab vedotin concentration in blood
Time Frame: Through 1 month after last dose
Through 1 month after last dose
Antitherapeutic antibodies in blood
Time Frame: Through 1 month after last dose
Through 1 month after last dose
Best clinical response
Time Frame: Through 1 month after last dose
Through 1 month after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Naomi Hunder, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

January 29, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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