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A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory CD30-positive Non-Hodgkin Lymphoma (NHL)


Phase 2
6 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell

Thank you

Trial Information

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory CD30-positive Non-Hodgkin Lymphoma (NHL)


Inclusion Criteria:



- Histologically-confirmed CD30-positive NHL

- Relapsed or refractory disease following at least 1 prior systemic therapy

- Measurable disease of at least 1.5 cm as documented by CT

- ECOG performance status less than or equal to 2

Exclusion Criteria:

- History of another primary invasive malignancy that has not been in remission for at
least 3 years

- Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis
fungoides

- B cell lymphoma previously treated with only single-agent rituximab (for patients
receiving brentuximab vedotin only) or corticosteroids as monotherapy

- Known cerebral/meningeal disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate with brentuximab vedotin

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:

No

Principal Investigator

Laurie Grove, PA-C

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-012

NCT ID:

NCT01421667

Start Date:

August 2011

Completion Date:

March 2016

Related Keywords:

  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Antigens, CD30
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Lymphoma, Non-Hodgkin
  • Monomethyl auristatin E
  • Drug Therapy
  • Immunotherapy
  • Hematologic Diseases
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Hackensack University Medical Center Hackensack, New Jersey  07601
Charles A. Sammons Cancer Center Dallas, Texas  75246
Stanford Cancer Center Stanford, California  94305-5824
City of Hope Duarte, California  91010
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Northwestern University Chicago, Illinois  60611
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
University of Chicago Chicago, Illinois  60637
Columbia University Medical Center New York, New York  10032
Puget Sound Cancer Centers Edmonds, Washington  98026
Emory Winship Cancer Institute Atlanta, Georgia  30322
Northwest Cancer Specialists, P.C. Portland, Oregon  97227
Rocky Mountain Cancer Centers - Aurora Aurora, Colorado  80012
Saint Francis Hospital Greenville, South Carolina  29601
Texas Oncology - Tyler Tyler, Texas  75702
Colorado Blood Cancer Institute Denver, Colorado  80218
MD Anderson Cancer Center / University of Texas Houston, Texas  77030-4003
Virginia Cancer Specialists, PC Fairfax, Virginia  22031
Seattle Cancer Care Alliance / University of Washington Medical Center Seattle, Washington  98109
Cleveland Clinic, The Cleveland, Ohio  44195
Texas Oncology - Seton Williamson Round Rock, Texas  78665
Minnesota Oncology Hematology P.A. Minneapolis, Minnesota  55404
Willamette Valley Cancer and Research / USOR Eugene, Oregon  97401
Texas Oncology-Southwest Fort Worth Fort Worth, Texas  76132
Cancer Specialists of North Florida - St. Augustine St. Augustine, Florida  32086