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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SGN-40, rituximab, etoposide, carboplatin, ifosfamide |
|
| 2 | Placebo Comparator | placebo, rituximab, etoposide, carboplatin, ifosfamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-40 | Drug | 2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Drachman, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| University of California at Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25651427 | Result | 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. |
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| placebo | Drug | Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15. |
|
| rituximab | Drug | 375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1 |
|
|
| etoposide | Drug | 100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3. |
|
|
| carboplatin | Drug | AUC=5 mg/mL min IV. Cycles 1-3: Day 2. |
|
|
| ifosfamide | Drug | 5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2. |
|
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305-5821 | United States |
| Christiana Care Health Systems | Newark | Delaware | 19718 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| MD Anderson Cancer Center, Orlando | Orlando | Florida | 32806 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Louisville - James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55416 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| St. Luke's Roosevelt Hospital Center | New York | New York | 10019 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4003 | United States |
| MultiCare Health System | Tacoma | Washington | 98405 | United States |
| West Virginia University | Morgantown | West Virginia | 26506-9162 | United States |
| St. Vincent's Hospital - Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Gosford & Wyong Hospital | Gosford | New South Wales | 2250 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| The Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| St. Vincent's Hospital, Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Universite de Gent | Ghent | 9000 | Belgium |
| AZ Sint-Augustinus | Wilrijk | 2610 | Belgium |
| Cliniques Universitaires UCL de Mont-Goddine | Yvoir | 5530 | Belgium |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Centre Hospitalier Andre Mignot | Le Chesnay | 78157 | France |
| Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes | Lyon | 69373 | France |
| Hopital Hotel Dieu | Nantes | 44093 | France |
| Groupe Hospitalier Necker - Enfants Malades | Paris | 75743 | France |
| Hopitaux du Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69485 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Hematologie CHU Purpan | Toulouse | 31059 | France |
| Institut Gustave-Roussy | Villejuif | 94805 | France |
| Johannes-Gutenberg Universitat Mainz | Mainz | 55101 | Germany |
| KH Maria Hilf-Franziskushaus | Mönchengladbach | 41063 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum | Debrecen | H-4012 | Hungary |
| Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine | Győr | H-9024 | Hungary |
| Kaposi Mor Oktato Korhaz | Kaposvár | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont | Szeged | H-6720 | Hungary |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50139 | Italy |
| Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Szpital Akademii Medycznej w Gdansku | Gdansk | 80-952 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz | 93-510 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-766 | Poland |
| Centrum Onkologii Institut im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 | Wroclaw | 50-367 | Poland |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Paul | Barcelona | 08041 | Spain |
| H. Duran y Reynals Institue Catala D'Oncologia | Barcelona | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D008232 | Lymphoproliferative Disorders |
| D008223 | Lymphoma |
| D006402 | Hematologic Diseases |
| D007160 | Immunoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C543331 | dacetuzumab |
| D000069283 | Rituximab |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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