A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
NCT ID: NCT00529503
Last Updated: 2015-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
151 participants
INTERVENTIONAL
2007-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
SGN-40
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
placebo
Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
Interventions
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SGN-40
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
placebo
Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.
* Received a hematopoietic stem cell transplant.
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Drachman, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Christiana Care Health Systems
Newark, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, United States
MD Anderson Cancer Center, Orlando
Orlando, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
St. Luke's Roosevelt Hospital Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor Sammons Cancer Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
MultiCare Health System
Tacoma, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
St. Vincent's Hospital - Sydney
Darlinghurst, New South Wales, Australia
Gosford & Wyong Hospital
Gosford, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
St. Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Universite de Gent
Ghent, , Belgium
AZ Sint-Augustinus
Wilrijk, , Belgium
Cliniques Universitaires UCL de Mont-Goddine
Yvoir, , Belgium
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centre Hospitalier Andre Mignot
Le Chesnay, , France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, , France
Hopital Hotel Dieu
Nantes, , France
Groupe Hospitalier Necker - Enfants Malades
Paris, , France
Hopitaux du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Hematologie CHU Purpan
Toulouse, , France
Institut Gustave-Roussy
Villejuif, , France
Johannes-Gutenberg Universitat Mainz
Mainz, , Germany
KH Maria Hilf-Franziskushaus
Mönchengladbach, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
Győr, , Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, , Hungary
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Szpital Akademii Medycznej w Gdansku
Gdansk, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, , Poland
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital de la Santa Creu i Sant Paul
Barcelona, , Spain
H. Duran y Reynals Institue Catala D'Oncologia
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Countries
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References
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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.
Other Identifiers
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SG040-0005
Identifier Type: -
Identifier Source: org_study_id
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