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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
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

Thank you

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 FoundationCleveland, Ohio  44195
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Georgetown UniversityWashington, District of Columbia  20007-2197
Northwestern UniversityChicago, Illinois  60611
Ohio State UniversityColumbus, Ohio  43210
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
San Juan Oncology AssociatesFarmington, New Mexico  87401
Multicare Health SystemTacoma, Washington  98415
West Virginia UniversityMorgantown, West Virginia  26506
Mayo Clinic RochesterRochester, Minnesota  55905
University of California at Los AngelesLos Angeles, California  90095
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Sarah Cannon Research InstituteNashville, Tennessee  37203
Park Nicollet InstituteSt Louis Park, Minnesota  55416
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Christiana Care Health SystemsNewark, Delaware  19718
MD Anderson Cancer Center, OrlandoOrlando, Florida  32806
University of Louisville - James Graham Brown Cancer CenterLouisville, Kentucky  40202
Baylor Sammons Cancer CenterDallas, Texas  75246