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

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01060904

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 MTD, PK, 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

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Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Vinblastine sulfate Vinblastine Dacarbazine Bleomycin Doxorubicin Doxorubicin hydrochloride Brentuximab Vedotin

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ]

Enrollment:	51
Study Start Date:	January 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
Measurable disease of at least 1.5 cm
ECOG 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01060904 History of Changes
Other Study ID Numbers:	SGN35-009
Study First Received:	January 29, 2010
Last Updated:	January 4, 2012
Health Authority:	United States: Food and Drug Administration

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:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Bleomycin
Doxorubicin
Dacarbazine
Vinblastine

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 23, 2012