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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:
ClinicalTrials.gov Identifier:
NCT00529503
First Posted: September 14, 2007
Last Update Posted: February 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
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.

Condition Intervention Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Drug: SGN-40 Drug: placebo Drug: rituximab Drug: etoposide Drug: carboplatin Drug: ifosfamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: 9 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 151
Study Start Date: September 2007
Study Completion Date: May 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
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: 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
Placebo Comparator: 2
placebo, rituximab, etoposide, carboplatin, ifosfamide
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529503


  Show 66 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech, Inc.
Investigators
Study Director: Jonathan Drachman, MD Seattle Genetics, Inc.
  More Information

Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00529503     History of Changes
Other Study ID Numbers: SG040-0005
First Submitted: September 11, 2007
First Posted: September 14, 2007
Last Update Posted: February 25, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Etoposide phosphate
Isophosphamide mustard
Carboplatin
Rituximab
Etoposide
Ifosfamide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents