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Lymphoma, Large B-Cell, DiffusePhase 2NCT00529503

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

A Phase 2 study testing SGN-40, rituximab and etoposide in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 66 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SGN-40, rituximab and etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
66 sitesin 10 countries
Study dates
Sep 2007to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

66 sites in 10 countries.

66 sites in 10 countries

United States24 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4003

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912

  • University of California at Los Angeles

    Los Angeles, California, 90095

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • West Virginia University

    Morgantown, West Virginia, 26506-9162

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • St. Luke's Roosevelt Hospital Center

    New York, New York, 10019

  • Christiana Care Health Systems

    Newark, Delaware, 19718

  • MD Anderson Cancer Center, Orlando

    Orlando, Florida, 32806

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55416

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5821

  • MultiCare Health System

    Tacoma, Washington, 98405

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

France9 sites

  • Centre Hospitalier Andre Mignot

    Le Chesnay, 78157

  • Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

    Lyon, 69373

  • Hopital Hotel Dieu

    Nantes, 44093

  • Groupe Hospitalier Necker - Enfants Malades

    Paris, 75743

  • Hopitaux du Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69485

  • Centre Henri Becquerel

    Rouen, 76038

  • Hematologie CHU Purpan

    Toulouse, 31059

  • Institut Gustave-Roussy

    Villejuif, 94805

Other trials in France

Australia6 sites

  • St. Vincent's Hospital - Sydney

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital, Melbourne

    Fitzroy, Victoria, 3065

  • Gosford & Wyong Hospital

    Gosford, New South Wales, 2250

  • The Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Poland6 sites

  • Szpital Akademii Medycznej w Gdansku

    Gdansk, 80-952

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-510

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-766

  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Wroclaw, 50-367

Other trials in Poland

Spain5 sites

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Paul

    Barcelona, 08041

  • H. Duran y Reynals Institue Catala D'Oncologia

    Barcelona

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Fe

    Valencia, 46009

Other trials in Spain

Hungary4 sites

  • Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum

    Debrecen, H-4012

  • Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine

    Győr, H-9024

  • Kaposi Mor Oktato Korhaz

    Kaposvár

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

    Szeged, H-6720

Other trials in Hungary

Belgium3 sites

  • Universite de Gent

    Ghent, 9000

  • AZ Sint-Augustinus

    Wilrijk, 2610

  • Cliniques Universitaires UCL de Mont-Goddine

    Yvoir, 5530

Other trials in Belgium

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Germany3 sites

  • Johannes-Gutenberg Universitat Mainz

    Mainz, 55101

  • KH Maria Hilf-Franziskushaus

    Mönchengladbach, 41063

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50139

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

Other trials in Italy

About this study

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)

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.

Being tested
SGN-40, placebo, rituximab, etoposide, carboplatin
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
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Lymphoma, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN-40Drug

    Also called dacetuzumab

    2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

  • placeboDrug

    Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.

  • rituximabDrug

    Also called Rituxan

    375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1

  • etoposideDrug

    Also called Toposar, Vepesid

    100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

  • carboplatinDrug

    Also called Paraplatin

    AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

  • ifosfamideDrug

    Also called Ifex

    5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Study groups in NCT00529503
Study groupRoleWhat they receive
1ExperimentalSGN-40, rituximab, etoposide, carboplatin, ifosfamide
Receives: Drug: SGN-40; Drug: rituximab; Drug: etoposide; Drug: carboplatin; Drug: ifosfamide
2Placebo comparatorplacebo, rituximab, etoposide, carboplatin, ifosfamide
Receives: Drug: placebo; Drug: rituximab; Drug: etoposide; Drug: carboplatin; Drug: ifosfamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 9 weeks

Secondary outcomes (2)

  1. Adverse events, laboratory values, and anti-drug antibody immune responses.

    Measured: 9 weeks

  2. Partial response, failure free survival, overall survival, and response for one and two years following treatment.

    Measured: Every 3 months for 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2009
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00529503
Sponsor's protocol ID
SG040-0005
Status last verified
Feb 2015
First submitted
11 Sep 2007
Last updated
25 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25651427

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGN-40, rituximab and etoposide in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 66 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, France, Australia, Poland, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00529503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015; AzTrials last refreshed its copy on 31 Oct 2026.

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