Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trials

Find Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trials Near You

A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

Status: Recruiting
Location: See all (152) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called previously untreated). Patients with DLBCL that have come back after treatment (called relapsed), or have not responded to treatment (called refractory), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug when combined with chemotherapy * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality of life and ability to complete routine daily activities

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)

• Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

• Life expectancy ≥ 12 months

• International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only

• Adequate hematologic and organ function, as defined in the protocol.

Locations
United States
California
David Geffen School of Medicine at UCLA
RECRUITING
Los Angeles
University of California Irvine Medical Center
RECRUITING
Orange
University of California (UC) Davis
RECRUITING
Sacramento
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
St Vincent Ascension at Peyton Manning Childrens Hospital
RECRUITING
Indianapolis
Investigative Clinical Research of Indiana
RECRUITING
Noblesville
Kentucky
University of Kentucky
RECRUITING
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
Henry Ford Health System
RECRUITING
Detroit
Cancer and Hematology Centers of Western Michigan
RECRUITING
Grand Rapids
North Carolina
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Clinical Research Alliance Inc
WITHDRAWN
Westbury
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Texas
Center for Oncology and Blood Disorders
WITHDRAWN
Houston
Utah
Community Cancer Trials of Utah
RECRUITING
Ogden
Wisconsin
Prohealth Care Inc
WITHDRAWN
Waukesha
Other Locations
Australia
Icon Cancer Centre - Wesley
RECRUITING
Auchenflower
Pindara Private Hospital
RECRUITING
Benowa
Epworth Freemasons
RECRUITING
East Melbourne
Liverpool Hospital
RECRUITING
Liverpool
Calvary Mater Newcastle
RECRUITING
Waratah
Austria
Medical University Graz
RECRUITING
Graz
Landeskrankenhaus Hochsteiermark
RECRUITING
Leoben
Kepler University Hospital
RECRUITING
Linz
Hanusch Krankenhaus
RECRUITING
Vienna
Medical University of Vienna
RECRUITING
Vienna
Klinikum Wels-Grieskirchen
RECRUITING
Wels
Belgium
Institut Jules Bordet
RECRUITING
Brussels
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
RECRUITING
Ghent
AZ St.-Elisabeth Herentals vzw
RECRUITING
Herentals
Az Delta
RECRUITING
Roeselare
Centre Hospitalier Regional de Verviers
RECRUITING
Verviers
Chile
Centro Oncologia de Precision Universidad Mayor
RECRUITING
Santiago
Clinica Alemana de Santiago
RECRUITING
Santiago
Hospital Clinico Universidad de Los Andes
RECRUITING
Santiago
Inmunocel
RECRUITING
Santiago
France
Centre Hospitalier Universitaire Angers
RECRUITING
Angers
Hopital Victor Dupouy Argenteuil
RECRUITING
Argenteuil
Avicenne Hospital
RECRUITING
Bobigny
Polyclinique Bordeaux Nord Aquitaine
RECRUITING
Bordeaux
Centre Hospitalier Metropole Savoie
RECRUITING
Chambéry
Hopital Saint Vincent-de-Paul
RECRUITING
Lille
Change Annecy
RECRUITING
Metz-tessy
Nantes University Hospital
RECRUITING
Nantes
CHU Nimes Institut de Cancerologie
RECRUITING
Nîmes
Assistance Publique-Hopitaux de Paris (AP-HP)
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Bordeaux
RECRUITING
Pessac
Centre Hospitalier Universitaire De Poitiers
RECRUITING
Poitiers
Centre Hospitalier Universitaire (CHU) Rennes
RECRUITING
Rennes
CHU de Saint-Etienne
RECRUITING
Saint-etienne
CHRU de Tours
RECRUITING
Tours
Gustave Roussy
RECRUITING
Villejuif
Germany
Hematological Praxis Dresden
RECRUITING
Dresden
University Hospital Carl Gustav Carus
RECRUITING
Dresden
University Hospital Essen
RECRUITING
Essen
Clinic Frankfurt (Oder)
RECRUITING
Frankfurt Am Main
Stadtisches Krankenhaus Kiel
RECRUITING
Kiel
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
RECRUITING
Mainz
Kliniken Ostalb Stauferklinikum Schwab Gmund
RECRUITING
Mutlangen
Robert-Bosch-Krankenhaus
RECRUITING
Stuttgart
Ireland
Beaumont Hospital
WITHDRAWN
Dublin
St James Hospital and Trinity College Dublin
RECRUITING
Dublin
Israel
Samson Assuta Ashdod University Hospital
RECRUITING
Ashdod
Bnai Zion Medical Center
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
The Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
The Chaim Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
Istituto Europeo di Oncologia
RECRUITING
Milan
A.O.U. di Modena
RECRUITING
Modena
ASST Monza Ospedale San Gerardo
RECRUITING
Monza
Federico II University
RECRUITING
Naples
AOU Maggiore della Carita
RECRUITING
Novara
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Ospedaliera di Perugia
RECRUITING
Perugia
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Hematology - Città della Salute e della Scienza di Torino
RECRUITING
Turin
Santa Maria della Misericordia
RECRUITING
Udine
Malaysia
Hospital Ampang
RECRUITING
Ampang
Hospital Queen Elizabeth
RECRUITING
Kota Kinabalu
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tg Ampuan Afzan
RECRUITING
Kuantan
Subang Jaya Medical Center
RECRUITING
Subang Jaya
Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
WITHDRAWN
Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
RECRUITING
Gdansk
Matopolskie Centrum Medyczne S.C.
RECRUITING
Krakow
Wielospecjalistyczne Centrum Onkologii i Traumatologii
RECRUITING
Lodz
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Pratia Poznan Medical Center
WITHDRAWN
Poznan
Aidport
RECRUITING
Skorzewo
Szpital Szpecjalistyczny w Walbrzychu
RECRUITING
Wałbrzych
Uniwersytecki Szpital Kliniczny
RECRUITING
Wroclaw
Republic of Korea
Dong-A University Hospital
RECRUITING
Busan
Inje University Busan Paik Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Yeyungnam University Medical Center
RECRUITING
Daegu
Keimyung University Dongsan Hospital
RECRUITING
Dalseo-gu
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul St Marys Hospital
RECRUITING
Seoul
Yeouido St. Marys Hospital
RECRUITING
Seoul
St. Vincent Hospital - The Catholic University of Korea
RECRUITING
Suwon
Singapore
National Cancer Centre of Singapore
RECRUITING
Singapore
National University Hospital Singapore
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Spain
Hospital Sant Pau
RECRUITING
Barcelona
Hospital Virgen De Las Nieves De Granada
RECRUITING
Granada
Fundacion Jimenez Diaz University Hospital
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Son Espases University Hospital
RECRUITING
Palma
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Clinico Universitario Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari Mutua Terrassa
RECRUITING
Terrassa
Hospital General Universitario de Toledo
WITHDRAWN
Toledo
Instituto Valenciano de Oncologia
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
RECRUITING
Valencia
University Hospital Doctor Peset
RECRUITING
Valencia
Taiwan
Chang Gung Medical Foundation Chia Yi Branch
RECRUITING
Buzi
Changhua Christian Hospital
RECRUITING
Changhua
Taipei Medical University - Shuang Ho Hospital
RECRUITING
New Taipei City
National Taiwan University Hospital
RECRUITING
Taipei
Wanfang Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch
RECRUITING
Taoyuan
Thailand
Chulalongkorn University
RECRUITING
Bangkok
Sriraj Hospital
RECRUITING
Bangkok
Chaing Mai University
RECRUITING
Chiang Mai
Faculty of Medicine
RECRUITING
Khon Kaen
Turkey
Gazi Universitesi
RECRUITING
Beşevler
Istanbul University Istanbul Faculty of Medicine
RECRUITING
Istanbul
Dokuz Eylul University
RECRUITING
Izmir
Ege University
RECRUITING
Izmir
VM Medical Park Mersin Hospital
RECRUITING
Mezitli
Sakarya University Medical Faculty
RECRUITING
Sakarya
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
RECRUITING
Samsun
Tekirdag Namik Kemal University Hospital
RECRUITING
Tekirdağ
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Yenimahalle
United Kingdom
NHS Grampian: Aberdeen Royal Infirmary
RECRUITING
Aberdeen
The Hillingdon Hospitals NHS Foundation Trust
RECRUITING
Uxbridge
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2029-09-12
Participants
Target number of participants: 904
Treatments
Experimental: Odronextamab + CHOP
Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).
Active_comparator: Rituximab + CHOP
Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov