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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01309789
First received: February 25, 2011
Last updated: September 17, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 39
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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: September 17, 2014
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:
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on November 24, 2014