A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
- Conditions
- Lymphoma, Non-HodgkinLymphoma, Large B-Cell, Diffuse
- Interventions
- Registration Number
- NCT00529503
- Lead Sponsor
- Seagen Inc.
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 151
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 carboplatin placebo, rituximab, etoposide, carboplatin, ifosfamide 2 ifosfamide placebo, rituximab, etoposide, carboplatin, ifosfamide 1 SGN-40 SGN-40, rituximab, etoposide, carboplatin, ifosfamide 2 placebo placebo, rituximab, etoposide, carboplatin, ifosfamide 1 rituximab SGN-40, rituximab, etoposide, carboplatin, ifosfamide 1 carboplatin SGN-40, rituximab, etoposide, carboplatin, ifosfamide 1 etoposide SGN-40, rituximab, etoposide, carboplatin, ifosfamide 1 ifosfamide SGN-40, rituximab, etoposide, carboplatin, ifosfamide 2 rituximab placebo, rituximab, etoposide, carboplatin, ifosfamide 2 etoposide placebo, rituximab, etoposide, carboplatin, ifosfamide
- Primary Outcome Measures
Name Time Method Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. 9 weeks
- Secondary Outcome Measures
Name Time Method Adverse events, laboratory values, and anti-drug antibody immune responses. 9 weeks Partial response, failure free survival, overall survival, and response for one and two years following treatment. Every 3 months for 2 years
Trial Locations
- Locations (66)
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
St. Vincent's Hospital, Melbourne
🇦🇺Fitzroy, Victoria, Australia
The Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Instytut Hematologii i Transfuzjologii
🇵🇱Warszawa, Poland
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, District of Columbia, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Park Nicollet Institute
🇺🇸St. Louis Park, Minnesota, United States
Azienda Ospedaliera Universitaria Careggi
🇮🇹Florence, Italy
Northwestern University
🇺🇸Chicago, Illinois, United States
Hopitaux du Haut Leveque
🇫🇷Pessac, France
Institut Gustave-Roussy
🇫🇷Villejuif, France
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czech Republic
Centre Hospitalier Andre Mignot
🇫🇷Le Chesnay, France
Centre Henri Becquerel
🇫🇷Rouen, France
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
MultiCare Health System
🇺🇸Tacoma, Washington, United States
Groupe Hospitalier Necker - Enfants Malades
🇫🇷Paris, France
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Ohio State University
🇺🇸Columbus, Ohio, United States
Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
St. Vincent's Hospital - Sydney
🇦🇺Darlinghurst, New South Wales, Australia
AZ Sint-Augustinus
🇧🇪Wilrijk, Belgium
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Hopital Hotel Dieu
🇫🇷Nantes, France
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Universite de Gent
🇧🇪Gent, Belgium
Cliniques Universitaires UCL de Mont-Goddine
🇧🇪Yvoir, Belgium
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Gosford & Wyong Hospital
🇦🇺Gosford, New South Wales, Australia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czech Republic
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Johannes-Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
KH Maria Hilf-Franziskushaus
🇩🇪Monchengladbach, Germany
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
🇫🇷Lyon, France
Hematologie CHU Purpan
🇫🇷Toulouse, France
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
ðŸ‡ðŸ‡ºSzeged, Hungary
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
ðŸ‡ðŸ‡ºDebrecen, Hungary
Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
ðŸ‡ðŸ‡ºGyor, Hungary
Kaposi Mor Oktato Korhaz
ðŸ‡ðŸ‡ºKaposvar, Hungary
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
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Wroclaw, Poland
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Paul
🇪🇸Barcelona, Spain
H. Duran y Reynals Institue Catala D'Oncologia
🇪🇸Barcelona, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
MD Anderson Cancer Center, Orlando
🇺🇸Orlando, Florida, United States
University of Louisville - James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, 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
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States