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:
Seattle Genetics, Inc.
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529503
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Hide Study LocationsLocations
| 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 June 18, 2013