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
Overview[ - collapse ][ - ]
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. |
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Condition | Lymphoma, Large-Cell, Anaplastic Lymphoma, NK-cell Lymphoma, T-cell |
Intervention | Drug: brentuximab vedotin Drug: cyclophosphamide Drug: brentuximab vedotin Drug: prednisone Drug: cyclophosphamide Drug: doxorubicin Drug: doxorubicin Drug: prednisone Drug: vincristine |
Phase | Phase 1 |
Sponsor | Seattle Genetics, Inc. |
Responsible Party | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier | NCT01309789 |
First Received | February 25, 2011 |
Last Updated | December 20, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | February 25, 2011 |
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Last Updated Date | December 20, 2013 |
Start Date | February 2011 |
Estimated Primary Completion Date | June 2015 |
Current Primary Outcome Measures | Incidence of adverse events and laboratory abnormalities [Time Frame: Through 1 month after last dose] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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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 |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: brentuximab vedotin 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16) Other Names: SGN-35Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks (Cycles 3-8) Drug: brentuximab vedotin 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) Other Names: SGN-35Drug: prednisone 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8) Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks (Cycles 1-6) Drug: doxorubicin 50 mg/m2 IV every 3 weeks (Cycles 3-8) 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) Drug: vincristine 1.4 mg/m2 IV every 3 weeks (Cycles 3-8) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 39 |
Estimated Completion Date | June 2015 |
Estimated Primary Completion Date | April 2013 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01309789 |
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Other Study ID Numbers | SGN35-011 |
Has Data Monitoring Committee | No |
Information Provided By | Seattle Genetics, Inc. |
Study Sponsor | Seattle Genetics, Inc. |
Collaborators | Millennium Pharmaceuticals, Inc. |
Investigators | Study Director: Dana Kennedy, PharmD, BCOP Seattle Genetics, Inc. |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
UAB Comprehensive Cancer Center | Birmingham, Alabama, United States, 35294-3300 |
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City of Hope National Medical Center | Duarte, California, United States, 91010 |
Stanford Cancer Center | Stanford, California, United States, 94305 |
Washington University School of Medicine | St. Louis, Missouri, United States, 63110 |
Memorial Sloan Kettering Cancer Center | New York, New York, United States, 10021 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania, United States, 19111 |
St. Francis Hospital | Greenville, South Carolina, United States, 29601 |
MD Anderson Cancer Center / University of Texas | Houston, Texas, United States, 77030-4000 |
Seattle Cancer Care Alliance / University of Washington Medical Center | Seattle, Washington, United States, 98109 |
Christie Hospital NHS Foundation Trust | Manchester, United Kingdom, M20 4BX |
Southampton General Hospital | Southampton, United Kingdom, SO16 6YD |