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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SGN-40
placebo
rituximab
etoposide
carboplatin
ifosfamide
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Lymphoproliferative Disorders, Lymphoma, Antigens, CD40, Antibody, Monoclonal, Combined Modality Therapy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California at Los Angeles
  • Stanford University Medical Center
  • Christiana Care Health Systems
  • Georgetown University
  • MD Anderson Cancer Center, Orlando
  • Winship Cancer Institute, Emory University
  • Northwestern University
  • University of Louisville - James Graham Brown Cancer Center
  • Sparrow Regional Cancer Center
  • Mayo Clinic Rochester
  • Park Nicollet Institute
  • Washington University School of Medicine
  • San Juan Oncology Associates
  • St. Luke's Roosevelt Hospital Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • Providence Portland Medical Center
  • Medical University of South Carolina
  • Sarah Cannon Research Institute
  • Baylor Sammons Cancer Center
  • University of Texas MD Anderson Cancer Center
  • MultiCare Health System
  • West Virginia University
  • St. Vincent's Hospital - Sydney
  • Gosford & Wyong Hospital
  • Royal North Shore Hospital
  • The Royal Brisbane and Women's Hospital
  • St. Vincent's Hospital, Melbourne
  • Royal Perth Hospital
  • Universite de Gent
  • AZ Sint-Augustinus
  • Cliniques Universitaires UCL de Mont-Goddine
  • Fakultni nemocnice Hradec Kralove
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice v Motole
  • Centre Hospitalier Andre Mignot
  • Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
  • Hopital Hotel Dieu
  • Groupe Hospitalier Necker - Enfants Malades
  • Hopitaux du Haut Leveque
  • Centre Hospitalier Lyon Sud
  • Centre Henri Becquerel
  • Hematologie CHU Purpan
  • Institut Gustave-Roussy
  • Johannes-Gutenberg Universitat Mainz
  • KH Maria Hilf-Franziskushaus
  • Universitatsklinikum Ulm
  • Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
  • Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
  • Kaposi Mor Oktato Korhaz
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera Universitaria San Martino
  • Azienda Ospedaliera Universitaria Senese
  • Szpital Akademii Medycznej w Gdansku
  • Szpital Uniwersytecki w Krakowie
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Instytut Hematologii i Transfuzjologii
  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Hospital Clinic i Provincial
  • Hospital de la Santa Creu i Sant Paul
  • H. Duran y Reynals Institue Catala D'Oncologia
  • Hospital Ramon y Cajal
  • Hospital Universitario La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

SGN-40, rituximab, etoposide, carboplatin, ifosfamide

placebo, rituximab, etoposide, carboplatin, ifosfamide

Outcomes

Primary Outcome Measures

Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.

Secondary Outcome Measures

Adverse events, laboratory values, and anti-drug antibody immune responses.
Partial response, failure free survival, overall survival, and response for one and two years following treatment.

Full Information

First Posted
September 11, 2007
Last Updated
February 6, 2015
Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00529503
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo, rituximab, etoposide, carboplatin, ifosfamide
Intervention Type
Drug
Intervention Name(s)
SGN-40
Other Intervention Name(s)
dacetuzumab
Intervention Description
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
Toposar, Vepesid
Intervention Description
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Other Intervention Name(s)
Ifex
Intervention Description
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
Primary Outcome Measure Information:
Title
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time Frame
9 weeks
Title
Partial response, failure free survival, overall survival, and response for one and two years following treatment.
Time Frame
Every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Drachman, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5821
Country
United States
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MD Anderson Cancer Center, Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Louisville - James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Institute
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4003
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States
Facility Name
St. Vincent's Hospital - Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Gosford & Wyong Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
St. Vincent's Hospital, Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Universite de Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Goddine
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Centre Hospitalier Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Groupe Hospitalier Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopitaux du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69485
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hematologie CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Johannes-Gutenberg Universitat Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
KH Maria Hilf-Franziskushaus
City
Monchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz
City
Kaposvar
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Szpital Akademii Medycznej w Gdansku
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-766
Country
Poland
Facility Name
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Paul
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
H. Duran y Reynals Institue Catala D'Oncologia
City
Barcelona
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25651427
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.
Results Reference
result

Learn more about this trial

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

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