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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Clínic 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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