A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Both
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Trial Information
A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Inclusion Criteria:
- Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.
- Received at least four cycles of first-line therapy with R-CHOP, or equivalent.
- Best clinical response to first-line therapy of stable disease, partial response, or
complete response.
- At least one measureable lesion that is both greater than or equal to 1.5cm by
radiographic imaging and by positive FDG-PET scan.
Exclusion Criteria:
- Leptomeningeal or central nervous system lymphoma.
- Received any therapy for relapsed or progressive disease except for local radiation,
steroids, or rituximab.
- Received a hematopoietic stem cell transplant.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Outcome Time Frame:
9 weeks
Safety Issue:
No
Principal Investigator
Jonathan Drachman, MD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SG040-0005
NCT ID:
NCT00529503
Start Date:
September 2007
Completion Date:
May 2011
Related Keywords:
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Lymphoma
- Antigens, CD40
- Antibody, Monoclonal
- Combined Modality Therapy
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Hematologic Diseases
- Immunoproliferative Disorders
- Lymphatic Diseases
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large B-Cell, Diffuse
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Northwestern University | Chicago, Illinois 60611 |
| Ohio State University | Columbus, Ohio 43210 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| San Juan Oncology Associates | Farmington, New Mexico 87401 |
| Multicare Health System | Tacoma, Washington 98415 |
| West Virginia University | Morgantown, West Virginia 26506 |
| Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| University of California at Los Angeles | Los Angeles, California 90095 |
| Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Park Nicollet Institute | St Louis Park, Minnesota 55416 |
| St. Luke's Roosevelt Hospital Center | New York, New York 10019 |
| Christiana Care Health Systems | Newark, Delaware 19718 |
| MD Anderson Cancer Center, Orlando | Orlando, Florida 32806 |
| University of Louisville - James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Baylor Sammons Cancer Center | Dallas, Texas 75246 |
