A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

This study has been terminated.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00529503
First received: September 11, 2007
Last updated: October 7, 2011
Last verified: October 2011

September 11, 2007
October 7, 2011
September 2007
December 2009   (final data collection date for primary outcome measure)
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00529503 on ClinicalTrials.gov Archive Site
  • Adverse events, laboratory values, and anti-drug antibody immune responses. [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • Partial response, failure free survival, overall survival, and response for one and two years following treatment. [ Time Frame: Every 3 months for 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
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)

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Drug: SGN-40
    2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
    Other Name: dacetuzumab
  • Drug: placebo
    Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
  • Drug: rituximab
    375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
    Other Name: Rituxan
  • Drug: etoposide
    100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
    Other Name: Toposar, Vepesid
  • Drug: carboplatin
    AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
    Other Name: Paraplatin
  • Drug: ifosfamide
    5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
    Other Name: Ifex
  • Experimental: 1
    SGN-40, rituximab, etoposide, carboplatin, ifosfamide
    Interventions:
    • Drug: SGN-40
    • Drug: rituximab
    • Drug: etoposide
    • Drug: carboplatin
    • Drug: ifosfamide
  • Placebo Comparator: 2
    placebo, rituximab, etoposide, carboplatin, ifosfamide
    Interventions:
    • Drug: placebo
    • Drug: rituximab
    • Drug: etoposide
    • Drug: carboplatin
    • Drug: ifosfamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
151
May 2011
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
 
NCT00529503
SG040-0005
Yes
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Genentech, Inc.
Study Director: Jonathan Drachman, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP