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

February 6, 2015 updated by: Seagen Inc.

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital - Sydney
      • Gosford, New South Wales, Australia, 2250
        • Gosford & Wyong Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • The Royal Brisbane and Women's Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital, Melbourne
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Belgium
      • Gent, Belgium, 9000
        • Université de Gent
      • Wilrijk, Belgium, 2610
        • AZ Sint-Augustinus
      • Yvoir, Belgium, 5530
        • Cliniques Universitaires UCL de Mont-Goddine
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Praha 2, Czech Republic, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 5, Czech Republic, 150 06
        • Fakultni nemocnice v Motole
  • France
      • Le Chesnay, France, 78157
        • Centre Hospitalier André Mignot
      • Lyon, France, 69373
        • Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
      • Nantes, France, 44093
        • Hôpital Hôtel Dieu
      • Paris, France, 75743
        • Groupe Hospitalier Necker - Enfants Malades
      • Pessac, France, 33604
        • Hopitaux du Haut Leveque
      • Pierre Benite, France, 69485
        • Centre Hospitalier Lyon Sud
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 31059
        • Hématologie CHU Purpan
      • Villejuif, France, 94805
        • Institut Gustave-Roussy
  • Germany
      • Mainz, Germany, 55101
        • Johannes-Gutenberg Universitat Mainz
      • Monchengladbach, Germany, 41063
        • KH Maria Hilf-Franziskushaus
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
  • Hungary
      • Debrecen, Hungary, H-4012
        • Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum
      • Gyor, Hungary, H-9024
        • Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine
      • Kaposvar, Hungary
        • Kaposi Mór Oktató Kórház
      • Szeged, Hungary, H-6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
  • Italy
      • Florence, Italy, 50139
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Poland
      • Gdansk, Poland, 80-952
        • Szpital Akademii Medycznej w Gdansku
      • Krakow, Poland, 31-501
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 93-510
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
      • Warszawa, Poland, 02-766
        • Instytut Hematologii I Transfuzjologii
      • Warszawa, Poland, 02-781
        • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
      • Wroclaw, Poland, 50-367
        • Samodzielny Publiczny Szpital Kliniczny nr 1
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Paul
      • Barcelona, Spain
        • H. Duran y Reynals Institue Catala D'Oncologia
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
      • Stanford, California, United States, 94305-5821
        • Stanford University Medical Center
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Systems
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center, Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - James Graham Brown Cancer Center
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Regional Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Institute
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt Hospital Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Sammons Cancer Center
      • Houston, Texas, United States, 77030-4003
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9162
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
Drug: SGN-40
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
Other Names:
  • dacetuzumab
Drug: rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
Other Names:
  • Rituxan
Drug: etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
Other Names:
  • Toposar, Vepesid
Drug: carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
Other Names:
  • Paraplatin
Drug: ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
Other Names:
  • Ifex
Placebo Comparator: 2
placebo, rituximab, etoposide, carboplatin, ifosfamide
Drug: rituximab
375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
Other Names:
  • Rituxan
Drug: etoposide
100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
Other Names:
  • Toposar, Vepesid
Drug: carboplatin
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
Other Names:
  • Paraplatin
Drug: ifosfamide
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
Other Names:
  • Ifex
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time Frame: 9 weeks
9 weeks
Partial response, failure free survival, overall survival, and response for one and two years following treatment.
Time Frame: Every 3 months for 2 years
Every 3 months for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Jonathan Drachman, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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