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
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529503

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305-5821
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
MD Anderson Cancer Center, Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kentucky
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Michigan
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4003
United States, Washington
MultiCare Health System
Tacoma, Washington, United States, 98405
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506-9162
Australia, New South Wales
St. Vincent's Hospital - Sydney
Darlinghurst, New South Wales, Australia, 2010
Gosford & Wyong Hospital
Gosford, New South Wales, Australia, 2250
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, Victoria
St. Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Belgium
Universite de Gent
Gent, Belgium, 9000
AZ Sint-Augustinus
Wilrijk, Belgium, 2610
Cliniques Universitaires UCL de Mont-Goddine
Yvoir, Belgium, 5530
Czech Republic
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Vseobecna fakultni nemocnice v Praze
Praha 2, Czech Republic, 128 08
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
France
Centre Hospitalier Andre Mignot
Le Chesnay, France, 78157
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, France, 69373
Hopital Hotel Dieu
Nantes, France, 44093
Groupe Hospitalier Necker - Enfants Malades
Paris, France, 75743
Hopitaux du Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69485
Centre Henri Becquerel
Rouen, France, 76038
Hematologie CHU Purpan
Toulouse, France, 31059
Institut Gustave-Roussy
Villejuif, France, 94805
Germany
Johannes-Gutenberg Universitat Mainz
Mainz, Germany, 55101
KH Maria Hilf-Franziskushaus
Monchengladbach, Germany, 41063
Universitatsklinikum Ulm
Ulm, Germany, 89081
Hungary
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
Debrecen, Hungary, H-4012
Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
Gyor, Hungary, H-9024
Kaposi Mor Oktato Korhaz
Kaposvar, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, Hungary, H-6720
Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50139
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Poland
Szpital Akademii Medycznej w Gdansku
Gdansk, Poland, 80-952
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Instytut Hematologii i Transfuzjologii
Warszawa, Poland, 02-766
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, Poland, 50-367
Spain
Hospital de la Santa Creu i Sant Paul
Barcelona, Spain, 08041
H. Duran y Reynals Institue Catala D'Oncologia
Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech
Investigators
Study Director: Jonathan Drachman, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00529503     History of Changes
Other Study ID Numbers: SG040-0005
Study First Received: September 11, 2007
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

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
Etoposide phosphate
Isophosphamide mustard
Rituximab
Ifosfamide
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014