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Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study


Phase 2
6 Years
N/A
Not Enrolling
Both
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

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Trial Information

Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study


Inclusion Criteria:



- Participated in a previous SGN-35 study.

- CD30-positive hematologic malignancy.

- At a minimum, experienced clinical benefit in the prior SGN-35 study. For
retreatment, patients must have previously achieved either complete or partial
remission with SGN-35 and experienced disease progression after discontinuing the
prior SGN-35 study.

Exclusion Criteria:

Withdrew consent to participate in any prior SGN-35 study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy 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 following last dose

Safety Issue:

Yes

Principal Investigator

Laurie Grove, PA-C

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-006

NCT ID:

NCT00947856

Start Date:

July 2009

Completion Date:

March 2013

Related Keywords:

  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD30
  • Drug Therapy
  • Hematologic Diseases
  • Immunotherapy
  • Monomethylauristatin E
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110
Charles A. Sammons Cancer Center Dallas, Texas  75246
City of Hope National Medical Center Los Angeles, California  91010
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Stanford Cancer Center Stanford, California  94305-5824
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Columbia University Medical Center New York, New York  10032
NYU Clinical Cancer Center New York, New York  10016
Colorado Blood Cancer Institute Denver, Colorado  80218
Karmanos Cancer Institute / Wayne State University Detroit, Michigan  48201
Loyola University Medical Center - Cardinal Bernadin Cancer Center Maywood, Illinois  60153
St. Francis Medical Group Oncology & Hematology Specialists Indianapolis, Indiana  46237
The John Theurer Cancer Center, Hackensack University Medical Center Hackensack, New Jersey  07601
Seattle Cancer Care Alliance / University of Washington Medical Center Seattle, Washington  98109
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center Miami, Florida  33136
MD Anderson Cancer Center /The University of Texas Houston, Texas  77030