Non Hodgkin Lymphoma Clinical Trial
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.
In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Eligibility Criteria
Inclusion Criteria:
Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
DLBCL, Not Otherwise Specified (NOS).
High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
T-cell/histiocyte-rich large B-cell lymphoma.
Epstein Barr virus-positive DLBCL, NOS.
Follicular lymphoma Grade 3b.
Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
Has at least one target lesion defined as:
>= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
Positron emission tomography (PET)-positive on PET-CT scan.
Laboratory values meeting the criteria laid out in the protocol.
Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
Exclusion Criteria:
History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
Clinically significant cardiovascular disease as per the protocol.
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There are 251 Locations for this study
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Fountain Valley California, 92708, United States
Laguna Hills California, 92653, United States
Long Beach California, 90806, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orlando Florida, 32806, United States
Springfield Illinois, 62702, United States
Fort Wayne Indiana, 46845, United States
Goshen Indiana, 46526, United States
Des Moines Iowa, 50314, United States
Louisville Kentucky, 40207, United States
Bethesda Maryland, 20817, United States
Ypsilanti Michigan, 48197, United States
Saint Louis Park Minnesota, 55416, United States
Billings Montana, 59102, United States
East Brunswick New Jersey, 08816, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10065, United States
Cincinnati Ohio, 45267, United States
Portland Oregon, 97227, United States
Kingwood Texas, 77339, United States
Charlottesville Virginia, 22903, United States
Olympia Washington, 98506, United States
Tacoma Washington, 98405, United States
Liverpool New South Wales, 2170, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, 6009, Australia
Perth Western Australia, 6000, Australia
Sankt Poelten Niederoesterreich, 3100, Austria
Vienna Wien, 1090, Austria
Vienna Wien, 1160, Austria
Salzburg , 5020, Austria
Woluwe-Saint-Lambert Bruxelles-Capitale, 1200, Belgium
La Louvière Hainaut, 7100, Belgium
Liège Liege, 4000, Belgium
Godinne Namur, 5530, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Roeselare West-Vlaanderen, 8800, Belgium
Anderlecht , 1070, Belgium
Antwerp , 2020, Belgium
Brugge , 8000, Belgium
Curitiba Parana, 80060, Brazil
Jaú Sao Paulo, 17210, Brazil
São Paulo Sao Paulo, 01509, Brazil
São Paulo Sao Paulo, 05652, Brazil
Sao Paulo , 01323, Brazil
Sao Paulo , 01323, Brazil
Sao Paulo , 05403, Brazil
Plovdiv , 4002, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1756, Bulgaria
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 1, Canada
Brampton Ontario, L6R 3, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Beijing Beijing, 10007, China
Beijing Beijing, 10014, China
Beijing Beijing, 10019, China
Fuzhou Fujian, 35001, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51051, China
Harbin Heilongjiang, 15008, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Suzhou Jiangsu, 21500, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, 33000, China
Nanchang Jiangxi, 33002, China
Changchun Jilin, 13002, China
Shenyang Liaoning, 11000, China
Jinan Shandong, 25160, China
Shanghai Shanghai, 20003, China
Tianjin Tianjin, 30000, China
Tianjin Tianjin, 30002, China More Info
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Rijeka Primorsko-goranska Zupanija, 51000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Slavonski Brod , 35000, Croatia
Brno , 613 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Prague , 150 0, Czechia
Praha , 100 3, Czechia
Praha , 128 0, Czechia
Copenhagen Ø Hovedstaden, 2100, Denmark
Aarhus Midtjylland, 8200, Denmark
Roskilde Sjælland, 4000, Denmark
Odense C Syddanmark, 5000, Denmark
Vejle Syddanmark, 7100, Denmark
Nice Alpes-Maritimes, 06200, France
Marseille Bouches-du-Rhone, 13009, France
Rennes Bretagne, 35000, France
Dijon Cote-d Or, 21000, France
Limoges CEDEX 1 Franche-Comte, 87042, France
Montpellier Cedex 5 Herault, 34295, France
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
Lille Nord, 59037, France
Nantes Pays-de-la-Loire, 44000, France
Bayonne Pyrenees-Atlantiques, 64100, France
Pierre Benite CEDEX Rhone, 69495, France
Amiens CEDEX 1 Somme, 80054, France
Poitiers Vienne, 86000, France
Angers , 49933, France
Caen , 14033, France
Créteil , 94010, France
La Roche Sur Yon , 85000, France
La Tronche , 38700, France
Paris , 75010, France
Rouen , 76038, France
Saint-cloud , 92210, France
Athens Attiki, 11527, Greece
Athens Attiki, 11528, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Ioannina , 45500, Greece
Thessaloniki , 54636, Greece
Thessaloniki , 54639, Greece
Gyor Gyor-Moson-Sopron, 9024, Hungary
Debrecen Hajdu-Bihar, 4032, Hungary
Kaposvár Somogy, 7400, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1085, Hungary
Budapest , 1122, Hungary
Szeged , 6720, Hungary
Szekszard , 7100, Hungary
Haifa H_efa, 31096, Israel
Haifa H_efa, 49414, Israel
Kfar Saba HaMerkaz, 44281, Israel
Tel Aviv HaMerkaz, 69710, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91031, Israel
Jerusalem Yerushalayim, 91120, Israel
San Giovanni Rotondo Foggia, 71013, Italy
Milan Milano, 20132, Italy
Milan Milano, 20141, Italy
Candiolo Torino, 10060, Italy
Alessandria , 15100, Italy
Aviano , 33081, Italy
Brescia , 25123, Italy
Meldola , 47014, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Ravenna , 48121, Italy
Nagoya-shi Aichi, 460-0, Japan
Nagoya-shi Aichi, 464-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Matsuyama-shi Ehime, 790-8, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Fukushima-shi Fukushima, 960-1, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Tsukuba-shi Ibaraki, 305-8, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Kagoshima-shi Kagoshima, 890-8, Japan
Isehara-shi Kanagawa, 259-1, Japan
Sendai-shi Miyagi, 98085, Japan
Okayama-shi Okayama, 700-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto-ku Tokyo, 135-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seongnam-si Gyeonggido, 13620, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Ulsan Ulsan Gwang Yeogsi, 44033, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49201, Korea, Republic of
Daegu , 41931, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Almere Flevoland, 1315 , Netherlands
Apeldoorn Gelderland, 7334 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Hoorn Nh Noord-Holland, 1624 , Netherlands
Zaandam Noord-Holland, 1502 , Netherlands
Dordrecht Zuid-Holland, 3318 , Netherlands
Alkmaar , 1815 , Netherlands
Amersfoort , 3813 , Netherlands
Amsterdam , 1081 , Netherlands
Amsterdam , 1091 , Netherlands
Breda , 4818 , Netherlands
Den Haag , 2512 , Netherlands
Deventer , 7416 , Netherlands
Eindhoven , 5623 , Netherlands
Eindhoven , 5631 , Netherlands
Enschede , 7512 , Netherlands
Groningen , 9713 , Netherlands
Haarlem , 2035 , Netherlands
Leeuwarden , 8934 , Netherlands
Leiden , 2333 , Netherlands
Maastricht , 6229 , Netherlands
Nieuwegein , 3435 , Netherlands
Nijmegen , 6532 , Netherlands
S Hertogenbosch , 5223 , Netherlands
Tilburg , 5022 , Netherlands
Utrecht , 3582 , Netherlands
Takapuna Auckland, 0622, New Zealand
Christchurch Canterbury, 8011, New Zealand
Slupsk Pomorskie, 76-20, Poland
Kielce Swietokrzyskie, 25-73, Poland
Olsztyn Warminsko-mazurskie, 10-22, Poland
Pila Wielkopolskie, 64-92, Poland
Skorzewo Wielkopolskie, 60-18, Poland
Braga , 4710-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Rio Piedras , 00935, Puerto Rico
Johannesburg Gauteng, 2193, South Africa
Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0044, South Africa
Kuilsrivier Western Cape, 7580, South Africa
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
El Palmar Murcia, 30120, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Cordoba , 14004, Spain
Madrid , 28027, Spain
Madrid , 28031, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Lund Skane Lan, 224 8, Sweden
Boras Vastra Gotalands Lan, 501 8, Sweden
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Linkoping , 581 8, Sweden
Solna , 171 6, Sweden
Aarau Aargau, 5001, Switzerland
Thun Bern, 3600, Switzerland
Winterthur Zuerich, 8400, Switzerland
Kaohsiung City Kaohsiung, 833, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
London London, City Of, W2 1N, United Kingdom
Norwich Norfolk, NR4 7, United Kingdom
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