A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms - Full Text View

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01309789

Purpose

The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.

Condition	Intervention	Phase
Lymphoma, Large-Cell, Anaplastic Lymphoma, NK-cell Lymphoma, T-cell	Drug: brentuximab vedotin Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin Drug: vincristine	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 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate 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 ]
Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	February 2011
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Sequential	Drug: brentuximab vedotin 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16) Other Name: SGN-35 Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks (Cycles 3-8) Drug: prednisone 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8) Drug: doxorubicin 50 mg/m2 IV every 3 weeks (Cycles 3-8) Drug: vincristine 1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
Experimental: 2 Combination	Drug: brentuximab vedotin 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) Other Name: SGN-35 Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks (Cycles 1-6) Drug: doxorubicin 50 mg/m2 IV every 3 weeks (Cycles 1-6) Drug: prednisone 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
Experimental: 3 Brentuximab vedotin/CH-P Combination	Drug: brentuximab vedotin 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) Other Name: SGN-35 Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks (Cycles 1-6) Drug: doxorubicin 50 mg/m2 IV every 3 weeks (Cycles 1-6) Drug: prednisone 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
Measurable disease of at least 1.5 cm
ECOG performance status less than or equal to 2

Exclusion Criteria:

Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
History of another primary malignancy that has not been in remission for at least 3 years
Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309789

Locations

United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
St. Francis Hospital
Greenville, South Carolina, United States, 29601
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4000
United States, Washington
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States, 98109
United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Seattle Genetics, Inc.

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Dana Kennedy, PharmD, BCOP

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01309789 History of Changes
Other Study ID Numbers:	SGN35-011, 2010-022839-11
Study First Received:	February 25, 2011
Last Updated:	March 15, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy

Lymphoma
monomethyl auristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-cell
Lymphoma, NK-cell

Additional relevant MeSH terms:

Neoplasms
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Cyclophosphamide
Doxorubicin

Prednisone
Vincristine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids

ClinicalTrials.gov processed this record on May 23, 2012