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

Overview[ - collapse ][ - ]

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.
ConditionDisease, Hodgkin
InterventionDrug: brentuximab vedotin
Drug: doxorubicin
Drug: vinblastine
Drug: dacarbazine
Drug: bleomycin
Drug: brentuximab vedotin
PhasePhase 1
SponsorSeattle Genetics, Inc.
Responsible PartySeattle Genetics, Inc.
ClinicalTrials.gov IdentifierNCT01060904
First ReceivedJanuary 29, 2010
Last UpdatedNovember 7, 2012
Last verifiedNovember 2012

Tracking Information[ + expand ][ + ]

First Received DateJanuary 29, 2010
Last Updated DateNovember 7, 2012
Start DateJanuary 2010
Estimated Primary Completion DateSeptember 2012
Current Primary Outcome MeasuresIncidence of adverse events and laboratory abnormalities [Time Frame: Through 1 month after last dose] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Brentuximab vedotin concentration in blood [Time Frame: Through 1 month after last dose] [Designated as safety issue: No]
  • Antitherapeutic antibodies in blood [Time Frame: Through 1 month after last dose] [Designated as safety issue: Yes]
  • Best clinical response [Time Frame: Through 1 month after last dose] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
Official TitleA Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDisease, Hodgkin
InterventionDrug: brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
Other Names:
SGN-35Drug: 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
Study Arm (s)
  • Experimental: 1
    brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
  • Experimental: 2
    brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment51
Estimated Completion DateSeptember 2012
Estimated Primary Completion DateSeptember 2012
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada

Administrative Information[ + expand ][ + ]

NCT Number NCT01060904
Other Study ID NumbersSGN35-009
Has Data Monitoring CommitteeNo
Information Provided BySeattle Genetics, Inc.
Study SponsorSeattle Genetics, Inc.
CollaboratorsMillennium Pharmaceuticals, Inc.
Investigators Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
Verification DateNovember 2012

Locations[ + expand ][ + ]

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