Clinical trial NCT00529503: A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Keywords: Lymphoproliferative Disorders
Lymphoma
Antigens, CD40
Antibody, Monoclonal
Combined Modality Therapy
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-09-14
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
timeFrame: 9 weeks
Secondary outcomes:
measure: Adverse events, laboratory values, and anti-drug antibody immune responses.
timeFrame: 9 weeks
measure: Partial response, failure free survival, overall survival, and response for one and two years following treatment.
timeFrame: Every 3 months for 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Orlando
country: United States
facility: MD Anderson Cancer Center, Orlando
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: University of Louisville - James Graham Brown Cancer Center
state: Kentucky
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St. Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital - Sydney
state: New South Wales
city: Gosford
country: Australia
facility: Gosford & Wyong Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Herston
country: Australia
facility: The Royal Brisbane and Women's Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital, Melbourne
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Gent
country: Belgium
facility: Universite de Gent
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Goddine
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Praha 2
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czech Republic
facility: Fakultni nemocnice v Motole
city: Le Chesnay
country: France
facility: Centre Hospitalier Andre Mignot
city: Lyon
country: France
facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: Groupe Hospitalier Necker - Enfants Malades
city: Pessac
country: France
facility: Hopitaux du Haut Leveque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: Hematologie CHU Purpan
city: Villejuif
country: France
facility: Institut Gustave-Roussy
city: Mainz
country: Germany
facility: Johannes-Gutenberg Universitat Mainz
city: Monchengladbach
country: Germany
facility: KH Maria Hilf-Franziskushaus
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Gdansk
country: Poland
facility: Szpital Akademii Medycznej w Gdansku
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Paul
city: Barcelona
country: Spain
facility: H. Duran y Reynals Institue Catala D'Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Seagen Inc.
name: Jonathan Drachman, MD
role: STUDY_DIRECTOR
References:
citation: 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.