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Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435916
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : January 7, 2015
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Drug: SGN-40 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date : December 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1 Drug: SGN-40
1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
Other Name: dacetuzumab

Primary Outcome Measures :
  1. Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: Every 1 or 2 months ]

Secondary Outcome Measures :
  1. Progression-free survival, disease-free survival, and overall survival. [ Time Frame: Study duration ]
  2. Adverse events, laboratory values, and anti-drug antibody immune responses. [ Time Frame: Within 3 weeks of final infusion ]
  3. PK profile. [ Time Frame: Within 3 weeks of final infusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435916

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85259
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University Medical Center
Palo Alto, California, United States, 94305
Sharp Healthcare
San Diego, California, United States, 92123
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Minnesota
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29403
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech, Inc.
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Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.

Publications of Results:
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Responsible Party: Seattle Genetics, Inc. Identifier: NCT00435916     History of Changes
Other Study ID Numbers: SG040-0004
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: December 2014
Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40
Antibody, Monoclonal
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents