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.
ConditionLymphoma, Large-Cell, Anaplastic
Lymphoma, NK-cell
Lymphoma, T-cell
InterventionDrug: brentuximab vedotin
Drug: cyclophosphamide
Drug: brentuximab vedotin
Drug: prednisone
Drug: cyclophosphamide
Drug: doxorubicin
Drug: doxorubicin
Drug: prednisone
Drug: vincristine
PhasePhase 1
SponsorSeattle Genetics, Inc.
Responsible PartySeattle Genetics, Inc.
ClinicalTrials.gov IdentifierNCT01309789
First ReceivedFebruary 25, 2011
Last UpdatedDecember 20, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 25, 2011
Last Updated DateDecember 20, 2013
Start DateFebruary 2011
Estimated Primary Completion DateJune 2015
Current Primary Outcome MeasuresIncidence of adverse events and laboratory abnormalities [Time Frame: Through 1 month after last dose] [Designated as safety issue: Yes]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, NK-cell
  • Lymphoma, T-cell
InterventionDrug: 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)
  • Experimental: 1
    Sequential
  • Experimental: 2
    Combination
  • Experimental: 3 Brentuximab vedotin/CH-P
    Combination

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment39
Estimated Completion DateJune 2015
Estimated Primary Completion DateApril 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT01309789
Other Study ID NumbersSGN35-011
Has Data Monitoring CommitteeNo
Information Provided BySeattle Genetics, Inc.
Study SponsorSeattle Genetics, Inc.
CollaboratorsMillennium Pharmaceuticals, Inc.
Investigators Study Director: Dana Kennedy, PharmD, BCOP Seattle Genetics, Inc.
Verification DateDecember 2013

Locations[ + expand ][ + ]

UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
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