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Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL
This study is currently recruiting participants.
Verified by Seattle Genetics, Inc., October 2008
Sponsors and Collaborators: Seattle Genetics, Inc.
Genentech
Information provided by: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00655837
  Purpose

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
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Drug: SGN-40
Drug: Rituximab
Drug: Gemcitabine
Phase I

MedlinePlus related topics: Lymphatic Diseases Lymphoma
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Rituximab Immunoglobulins Globulin, Immune Dacetuzumab
U.S. FDA Resources
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)

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab. [ Time Frame: 10 months from registration of last patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy. [ Time Frame: Follow-up every 6 weeks after end of treatment. ] [ Designated as safety issue: No ]

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease
  • Must have at least one site of biopsy-proven disease demonstrating both of the following:

    • bidimensional measurable disease with the longest axis ≥1.5cm by radiographic imaging
    • positive FDG-PET scan at baseline
  • Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy
  • Either fresh or archived tumor specimen must be available

Exclusion Criteria:

  • Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms
  • Patients who have received allogeneic stem cell transplant
  • Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration
  • Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug
  • Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655837

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Andres Forero-Torres, MD            
United States, Arizona
Mayo Clinic AZ Recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Donald Northfelt, MD            
United States, Colorado
University of Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Han Myint, MD            
United States, Illinois
Oncology Specialists Recruiting
Park Ridge, Illinois, United States, 60068
Principal Investigator: Jacob Bitran, MD            
United States, Missouri
Washington University in St. Louis Not yet recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Nancy Bartlett, MD            
United States, Nevada
Nevada Cancer Institute Recruiting
Las Vegas, Nevada, United States, 89135
Principal Investigator: Nam Dang, MD            
United States, New York
North Shore University Hospital Recruiting
Lake Success, New York, United States, 11042
Principal Investigator: Jonathan Kolitz, MD            
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10017
Principal Investigator: Craig Moskowitz, MD            
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Anne Beaven, MD            
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Hossein Borghaei, DO            
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Charalambos Andreadis, MD            
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech
Investigators
Study Director: Nancy Whiting, Pharm.D. Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics ( Nancy Whiting Pharm.D., BCOP/ Medical Director )
Study ID Numbers: SG040-0008
Study First Received: April 4, 2008
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00655837  
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40,
Antibodies, Monoclonal
Combined Modality Therapy
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Rituximab
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, large-cell
Lymphatic Diseases
Antibodies
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Gemcitabine
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009