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Sponsors and Collaborators: |
Seattle Genetics, Inc. Genentech |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00655837 |
The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.
Condition | Intervention | Phase |
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Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin |
Drug: SGN-40 Drug: rituximab Drug: gemcitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
Estimated Enrollment: | 29 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SGN-40
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
Drug: rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
Drug: gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, Arizona | |
Mayo Clinic Arizona | |
Scottsdale, Arizona, United States, 85259 | |
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045-0510 | |
United States, Illinois | |
Oncology Specialists | |
Park Ridge, Illinois, United States, 60068 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, Nevada | |
Nevada Cancer Institute | |
Las Vegas, Nevada, United States, 89135 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | Nancy Whiting, PharmD | Seattle Genetics, Inc. |
Responsible Party: | Seattle Genetics ( Nancy Whiting Pharm.D., BCOP ) |
Study ID Numbers: | SG040-0008 |
Study First Received: | April 4, 2008 |
Last Updated: | August 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00655837 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antigens, CD40 Antibodies, Monoclonal Combined Modality Therapy Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin |
Hematologic Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Lymphoma |
Antimetabolites Anti-Infective Agents Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunologic Factors Hematologic Diseases Rituximab Immunosuppressive Agents Antiviral Agents Antibodies, Monoclonal Lymphoma, B-Cell |
Lymphatic Diseases Antibodies Radiation-Sensitizing Agents B-cell Lymphomas Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma, Large-cell Gemcitabine Lymphoma Immunoglobulins |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Lymphoma, B-Cell Therapeutic Uses Gemcitabine Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Radiation-Sensitizing Agents Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |