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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large-Cell, Anaplastic, Lymphoma, NK-cell, Lymphoma, T-cell

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and laboratory abnormalities

Outcome Time Frame:

Through 1 month after last dose

Safety Issue:

Yes

Principal Investigator

Dana Kennedy, PharmD, BCOP

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-011

NCT ID:

NCT01309789

Start Date:

February 2011

Completion Date:

June 2015

Related Keywords:

  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, NK-cell
  • Lymphoma, T-Cell
  • 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
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell
  • Lymphoma, Large-Cell, Anaplastic

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
City of Hope National Medical CenterLos Angeles, California  91010
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Stanford Cancer CenterStanford, California  94305-5824
St. Francis HospitalGreenville, South Carolina  29601
MD Anderson Cancer Center / University of TexasHouston, Texas  77030-4003
Seattle Cancer Care Alliance / University of Washington Medical CenterSeattle, Washington  98109