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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: Active_not_recruiting
Location: See all (146) 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
Los Angeles
University of California Irvine Medical Center
Orange
University of California (UC) Davis
Sacramento
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis
Investigative Clinical Research of Indiana
Noblesville
Kentucky
University of Kentucky
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Michigan
Henry Ford Health System
Detroit
Cancer and Hematology Centers of Western Michigan
Grand Rapids
North Carolina
Duke University Medical Center
Durham
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
New York
Stony Brook University Hospital
Stony Brook
Clinical Research Alliance Inc
Westbury
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Texas
Center for Oncology and Blood Disorders
Houston
Utah
Community Cancer Trials of Utah
Ogden
Wisconsin
Prohealth Care Inc
Waukesha
Other Locations
Australia
Icon Cancer Centre - Wesley
Auchenflower
Pindara Private Hospital
Benowa
Epworth Freemasons
East Melbourne
Liverpool Hospital
Liverpool
Calvary Mater Newcastle
Waratah
Austria
Medical University Graz
Graz
Landeskrankenhaus Hochsteiermark
Leoben
Kepler University Hospital
Linz
Hanusch Krankenhaus
Vienna
Medical University of Vienna
Vienna
Klinikum Wels-Grieskirchen
Wels
Belgium
Institut Jules Bordet
Brussels
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent
AZ St.-Elisabeth Herentals vzw
Herentals
Az Delta
Roeselare
Centre Hospitalier Regional de Verviers
Verviers
Chile
Centro Oncologia de Precision Universidad Mayor
Santiago
Clinica Alemana de Santiago
Santiago
Hospital Clinico Universidad de Los Andes
Santiago
Inmunocel
Santiago
France
Centre Hospitalier Universitaire Angers
Angers
Hopital Victor Dupouy Argenteuil
Argenteuil
Avicenne Hospital
Bobigny
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
Centre Hospitalier Metropole Savoie
Chambéry
Hopital Saint Vincent-de-Paul
Lille
Change Annecy
Metz-tessy
Nantes University Hospital
Nantes
CHU Nimes Institut de Cancerologie
Nîmes
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac
Centre Hospitalier Universitaire De Poitiers
Poitiers
Centre Hospitalier Universitaire (CHU) Rennes
Rennes
CHU de Saint-Etienne
Saint-etienne
CHRU de Tours
Tours
Gustave Roussy
Villejuif
Germany
Hematological Praxis Dresden
Dresden
University Hospital Carl Gustav Carus
Dresden
University Hospital Essen
Essen
Clinic Frankfurt (Oder)
Frankfurt Am Main
Stadtisches Krankenhaus Kiel
Kiel
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen
Robert-Bosch-Krankenhaus
Stuttgart
Ireland
St James Hospital and Trinity College Dublin
Dublin
Israel
Samson Assuta Ashdod University Hospital
Ashdod
Bnai Zion Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Galilee Medical Center
Nahariya
The Tel Aviv Sourasky Medical Center
Tel Aviv
The Chaim Sheba Medical Center
Tel Litwinsky
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Istituto Europeo di Oncologia
Milan
A.O.U. di Modena
Modena
ASST Monza Ospedale San Gerardo
Monza
Federico II University
Naples
AOU Maggiore della Carita
Novara
Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliera di Perugia
Perugia
Ospedale Santa Maria delle Croci
Ravenna
Hematology - Città della Salute e della Scienza di Torino
Turin
Santa Maria della Misericordia
Udine
Malaysia
Hospital Ampang
Ampang
Hospital Queen Elizabeth
Kota Kinabalu
University Malaya Medical Centre
Kuala Lumpur
Hospital Tg Ampuan Afzan
Kuantan
Subang Jaya Medical Center
Subang Jaya
Poland
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk
Matopolskie Centrum Medyczne S.C.
Krakow
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin
Aidport
Skorzewo
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych
Uniwersytecki Szpital Kliniczny
Wroclaw
Republic of Korea
Dong-A University Hospital
Busan
Inje University Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Keimyung University Dongsan Hospital
Daegu
Yeyungnam University Medical Center
Daegu
Gachon University Gil Medical Center
Incheon
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul St Marys Hospital
Seoul
Yeouido St. Marys Hospital
Seoul
St. Vincent Hospital - The Catholic University of Korea
Suwon
Singapore
National Cancer Centre of Singapore
Singapore
National University Hospital Singapore
Singapore
Tan Tock Seng Hospital
Singapore
Spain
Hospital Sant Pau
Barcelona
Hospital Virgen De Las Nieves De Granada
Granada
Fundacion Jimenez Diaz University Hospital
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Central de Asturias
Oviedo
Son Espases University Hospital
Palma
Hospital Universitario de Navarra
Pamplona
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcón
Hospital Universitari Parc Tauli
Sabadell
Hospital Universitario Marques de Valdecilla
Santander
Hospital Clinico Universitario Santiago de Compostela
Santiago De Compostela
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Universitari Mutua Terrassa
Terrassa
Instituto Valenciano de Oncologia
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia
University Hospital Doctor Peset
Valencia
Taiwan
Chang Gung Medical Foundation Chia Yi Branch
Buzi
Changhua Christian Hospital
Changhua
Taipei Medical University - Shuang Ho Hospital
New Taipei City
National Taiwan University Hospital
Taipei
Wanfang Hospital
Taipei
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District
Thailand
Chulalongkorn University
Bangkok
Sriraj Hospital
Bangkok
Chaing Mai University
Chiang Mai
Faculty of Medicine
Khon Kaen
Turkey
Gazi Universitesi
Beşevler
Istanbul University Istanbul Faculty of Medicine
Istanbul
Dokuz Eylul University
Izmir
Ege University
Izmir
VM Medical Park Mersin Hospital
Mezitli
Sakarya University Medical Faculty
Sakarya
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun
Tekirdag Namik Kemal University Hospital
Tekirdağ
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle
United Kingdom
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge
Time Frame
Start Date: 2023-12-13
Completion Date: 2029-09-02
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

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