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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060904
First Posted: February 2, 2010
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
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.

Condition Intervention Phase
Disease, Hodgkin Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: bleomycin Phase 1

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ]

Secondary Outcome Measures:
  • Brentuximab vedotin concentration in blood [ Time Frame: Through 1 month after last dose ]
  • Antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ]
  • Best clinical response [ Time Frame: Through 1 month after last dose ]

Enrollment: 51
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Experimental: 2
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
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 Name: SGN-35

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060904


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
  More Information

Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01060904     History of Changes
Other Study ID Numbers: SGN35-009
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Disease, Hodgkin
Hematologic Diseases
Immunotherapy
Lymphoma
monomethyl auristatin E

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Doxorubicin
Liposomal doxorubicin
Bleomycin
Vinblastine
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators