A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

PHASE2TerminatedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

May 31, 2011

Conditions
Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin
Interventions
DRUG

SGN-40

2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

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

DRUG

etoposide

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

DRUG

carboplatin

AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

DRUG

ifosfamide

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Trial Locations (66)

2010

St. Vincent's Hospital - Sydney, Darlinghurst

2065

Royal North Shore Hospital, St Leonards

2250

Gosford & Wyong Hospital, Gosford

2610

AZ Sint-Augustinus, Wilrijk

3065

St. Vincent's Hospital, Melbourne, Fitzroy

4029

The Royal Brisbane and Women's Hospital, Herston

5530

Cliniques Universitaires UCL de Mont-Goddine, Yvoir

6000

Royal Perth Hospital, Perth

9000

Universite de Gent, Ghent

10019

St. Luke's Roosevelt Hospital Center, New York

16132

Azienda Ospedaliera Universitaria San Martino, Genova

19718

Christiana Care Health Systems, Newark

20007

Georgetown University, Washington D.C.

28034

Hospital Ramon y Cajal, Madrid

29425

Medical University of South Carolina, Charleston

30322

Winship Cancer Institute, Emory University, Atlanta

31059

Hematologie CHU Purpan, Toulouse

32806

MD Anderson Cancer Center, Orlando, Orlando

33604

Hopitaux du Haut Leveque, Pessac

37203

Sarah Cannon Research Institute, Nashville

40202

University of Louisville - James Graham Brown Cancer Center, Louisville

41063

KH Maria Hilf-Franziskushaus, Mönchengladbach

43210

Ohio State University, Columbus

44093

Hopital Hotel Dieu, Nantes

44195

Cleveland Clinic Foundation, Cleveland

46009

Hospital Universitario La Fe, Valencia

48912

Sparrow Regional Cancer Center, Lansing

50139

Azienda Ospedaliera Universitaria Careggi, Florence

53100

Azienda Ospedaliera Universitaria Senese, Siena

55101

Johannes-Gutenberg Universitat Mainz, Mainz

55416

Park Nicollet Institute, Saint Louis Park

55905

Mayo Clinic Rochester, Rochester

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

69373

Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon

69485

Centre Hospitalier Lyon Sud, Pierre-Bénite

75246

Baylor Sammons Cancer Center, Dallas

75743

Groupe Hospitalier Necker - Enfants Malades, Paris

76038

Centre Henri Becquerel, Rouen

78157

Centre Hospitalier Andre Mignot, Le Chesnay

87401

San Juan Oncology Associates, Farmington

89081

Universitatsklinikum Ulm, Ulm

90095

University of California at Los Angeles, Los Angeles

94805

Institut Gustave-Roussy, Villejuif

97213

Providence Portland Medical Center, Portland

98405

MultiCare Health System, Tacoma

35294-3300

University of Alabama at Birmingham, Birmingham

94305-5821

Stanford University Medical Center, Stanford

77030-4003

University of Texas MD Anderson Cancer Center, Houston

26506-9162

West Virginia University, Morgantown

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

128 08

Vseobecna fakultni nemocnice v Praze, Prague

150 06

Fakultni nemocnice v Motole, Prague

H-4012

Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Debrecen

H-9024

Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine, Győr

Unknown

Kaposi Mor Oktato Korhaz, Kaposvár

H. Duran y Reynals Institue Catala D'Oncologia, Barcelona

H-6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont, Szeged

80-952

Szpital Akademii Medycznej w Gdansku, Gdansk

31-501

Szpital Uniwersytecki w Krakowie, Krakow

93-510

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

02-766

Instytut Hematologii i Transfuzjologii, Warsaw

02-781

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie, Warsaw

50-367

Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw

08036

Hospital Clinic i Provincial, Barcelona

08041

Hospital de la Santa Creu i Sant Paul, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Seagen Inc.

INDUSTRY

NCT00529503 - A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL | Biotech Hunter | Biotech Hunter