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

NCT00529503 | Terminated Phase 2 DMC

• 1 other identifier: SG040-0005
• Study Type: interventional
• Target: 151
• Locations: 10 countries
• Sites: 66

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  9 weeks

Secondary Outcomes (2)

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

  9 weeks

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

  Every 3 months for 2 years

Study Arms (2)

1

EXPERIMENTAL

SGN-40, rituximab, etoposide, carboplatin, ifosfamide

Drug: SGN-40; Drug: rituximab; Drug: etoposide; Drug: carboplatin; Drug: ifosfamide

2

PLACEBO COMPARATOR

placebo, rituximab, etoposide, carboplatin, ifosfamide

Drug: placebo; Drug: rituximab; Drug: etoposide; Drug: carboplatin; Drug: ifosfamide

Interventions

SGN-40 DRUG

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

Also known as: dacetuzumab

1

placebo DRUG

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

2

rituximab DRUG

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

Also known as: Rituxan

1; 2

etoposide DRUG

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

Also known as: Toposar, Vepesid

1; 2

carboplatin DRUG

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

Also known as: Paraplatin

1; 2

ifosfamide DRUG

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

Also known as: Ifex

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen Inc.: lead
• Genentech, Inc.: collaborator

Study Sites (66)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5821, United States

Location

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MD Anderson Cancer Center, Orlando

Orlando, Florida, 32806, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4003, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506-9162, United States

Location

St. Vincent's Hospital - Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Gosford & Wyong Hospital

Gosford, New South Wales, 2250, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

The Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

St. Vincent's Hospital, Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Universite de Gent

Ghent, 9000, Belgium

Location

AZ Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Cliniques Universitaires UCL de Mont-Goddine

Yvoir, 5530, Belgium

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Centre Hospitalier Andre Mignot

Le Chesnay, 78157, France

Location

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

Lyon, 69373, France

Location

Hopital Hotel Dieu

Nantes, 44093, France

Location

Groupe Hospitalier Necker - Enfants Malades

Paris, 75743, France

Location

Hopitaux du Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69485, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Hematologie CHU Purpan

Toulouse, 31059, France

Location

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Johannes-Gutenberg Universitat Mainz

Mainz, 55101, Germany

Location

KH Maria Hilf-Franziskushaus

Mönchengladbach, 41063, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum

Debrecen, H-4012, Hungary

Location

Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine

Győr, H-9024, Hungary

Location

Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

Szeged, H-6720, Hungary

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50139, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Szpital Akademii Medycznej w Gdansku

Gdansk, 80-952, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, 93-510, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02-766, Poland

Location

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Wroclaw, 50-367, Poland

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Paul

Barcelona, 08041, Spain

Location

H. Duran y Reynals Institue Catala D'Oncologia

Barcelona, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Related 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 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.

  PMID: 25651427 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoproliferative Disorders; Lymphoma; Hematologic Diseases; Immunoproliferative Disorders; Lymphatic Diseases

Interventions

dacetuzumab; Rituximab; Etoposide; Carboplatin; Ifosfamide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jonathan Drachman, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2011
• Last Updated: February 25, 2015

Record last verified: 2015-02

Locations

FR (9); BE (3); IT (3); ES (5); AU (6); CZ (3); PL (6); HU (4); US (24); DE (3)