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

Lymphoma, Non-Hodgkin Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00529503
• Other study ID #: SG040-0005
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2007
• Last updated: February 6, 2015
• Start date: September 2007
• Est. completion date: May 2011

Study information

• Verified date: February 2015
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 151
• Est. completion date: May 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• SGN-40
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
• placebo
Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
• rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
• etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
• carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
• ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital - Sydney	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital, Melbourne	Fitzroy	Victoria
Australia	Gosford & Wyong Hospital	Gosford	New South Wales
Australia	The Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Belgium	Universite de Gent	Gent
Belgium	AZ Sint-Augustinus	Wilrijk
Belgium	Cliniques Universitaires UCL de Mont-Goddine	Yvoir
Czech Republic	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czech Republic	Vseobecna fakultni nemocnice v Praze	Praha 2
Czech Republic	Fakultni nemocnice v Motole	Praha 5
France	Centre Hospitalier Andre Mignot	Le Chesnay
France	Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes	Lyon
France	Hopital Hotel Dieu	Nantes
France	Groupe Hospitalier Necker - Enfants Malades	Paris
France	Hopitaux du Haut Leveque	Pessac
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Henri Becquerel	Rouen
France	Hematologie CHU Purpan	Toulouse
France	Institut Gustave-Roussy	Villejuif
Germany	Johannes-Gutenberg Universitat Mainz	Mainz
Germany	KH Maria Hilf-Franziskushaus	Monchengladbach
Germany	Universitatsklinikum Ulm	Ulm
Hungary	Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine	Gyor
Hungary	Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont	Szeged
Italy	Azienda Ospedaliera Universitaria Careggi	Florence
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Poland	Szpital Akademii Medycznej w Gdansku	Gdansk
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	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	Samodzielny Publiczny Szpital Kliniczny Nr 1	Wroclaw
Spain	H. Duran y Reynals Institue Catala D'Oncologia	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Paul	Barcelona
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario La Fe	Valencia
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor Sammons Cancer Center	Dallas	Texas
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	University of California at Los Angeles	Los Angeles	California
United States	University of Louisville - James Graham Brown Cancer Center	Louisville	Kentucky
United States	West Virginia University	Morgantown	West Virginia
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Christiana Care Health Systems	Newark	Delaware
United States	MD Anderson Cancer Center, Orlando	Orlando	Florida
United States	Providence Portland Medical Center	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Park Nicollet Institute	St. Louis Park	Minnesota
United States	Stanford University Medical Center	Stanford	California
United States	MultiCare Health System	Tacoma	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Poland,  Spain, 

References & Publications (1)

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 lymp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.		9 weeks	No
Secondary	Adverse events, laboratory values, and anti-drug antibody immune responses.		9 weeks	Yes
Secondary	Partial response, failure free survival, overall survival, and response for one and two years following treatment.		Every 3 months for 2 years	No