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

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ClinicalTrials.gov Identifier: NCT00529503
Recruitment Status : Terminated
First Posted : September 14, 2007
Last Update Posted : February 25, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2007
First Posted Date  ICMJE September 14, 2007
Last Update Posted Date February 25, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: 9 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00529503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Adverse events, laboratory values, and anti-drug antibody immune responses. [ Time Frame: 9 weeks ]
  • Partial response, failure free survival, overall survival, and response for one and two years following treatment. [ Time Frame: Every 3 months for 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2010)
151
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00529503
Other Study ID Numbers  ICMJE SG040-0005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Director: Jonathan Drachman, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date February 2015

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