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Trial record 1 of 1 for:    NCT01309789
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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

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.
 
ClinicalTrials.gov Identifier: NCT01309789
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Large-Cell, Anaplastic Lymphoma, NK-cell Lymphoma, T-cell Drug: brentuximab vedotin Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin Drug: vincristine Phase 1

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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)


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

Secondary Outcome Measures :
  1. Brentuximab vedotin concentration in blood [ Time Frame: Through 1 month after last dose ]
  2. Antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ]
  3. Best clinical response [ Time Frame: Through 1 month after last dose ]
  4. Progression-free survival [ Time Frame: Until disease progression or study closure ]
  5. Overall survival [ Time Frame: Every 3 months until death or study closure ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01309789


Locations
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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
Saint 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
Seagen Inc.
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Dana Kennedy, PharmD, BCOP Seagen Inc.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT01309789    
Other Study ID Numbers: SGN35-011
2010-022839-11
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Keywords provided by Seagen Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
 Lymphoma
monomethyl auristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-cell
Lymphoma, NK-cell
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Vincristine
 Brentuximab Vedotin
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors