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A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

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Trial Information

A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)


Inclusion Criteria:



- Diagnosis of DLBCL.

- Received at least one combination chemotherapy regimen with rituximab, such as
R-CHOP, R-ESHAP or equivalent.

- Progression or relapse since most recent therapy.

- At least one measurable lesion that is both greater than or equal to 2 cm by
conventional CT or greater than or equal to 1.5 cm by spiral CT.

Exclusion Criteria:

- Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or
central nervous system lymphoma.

- Primary refractory disease.

- Received an allogenic stem cell transplant.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.

Outcome Time Frame:

Every 1 or 2 months

Safety Issue:

No

Principal Investigator

Nancy Whiting, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG040-0004

NCT ID:

NCT00435916

Start Date:

December 2006

Completion Date:

January 2009

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Antigens, CD40
  • Antibody, Monoclonal
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Hematologic Diseases
  • Immunoproliferative Disorders
  • Lymphatic Diseases
  • Lymphoproliferative Disorders
  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
Washington University School of Medicine Saint Louis, Missouri  63110
Swedish Cancer Institute Seattle, Washington  98104
Rush University Medical Center Chicago, Illinois  60612-3824
Weill Medical College of Cornell University New York, New York  10021
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of California Los Angeles Los Angeles, California  90095-6951
Georgetown University Washington, District of Columbia  20007-2197
Northwestern University Chicago, Illinois  60611
Sharp Healthcare San Diego, California  92121
University of Wisconsin Madison,, Wisconsin  53792-5666
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Mayo Clinic-Arizona Scottsdale, Arizona  85259
Mayo Clinic-Rochester Rochester, Minnesota  55905