Non Hodgkin Lymphoma Clinical Trial
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
Participant has:
Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
>= 1 measurable nodal lesion (long axis >= 1.5 cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with (an)other anti-lymphoma agent(s).
Eligible to receive R2 per investigator determination.
Exclusion Criteria:
Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.
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There are 275 Locations for this study
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Berkeley California, 94705, 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
Aurora Colorado, 80014, United States
Jacksonville Florida, 32207, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Goshen Indiana, 46526, United States
Baton Rouge Louisiana, 70808, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Saint Louis Park Minnesota, 55416, United States
Chesterfield Missouri, 63017, United States
Kansas City Missouri, 64114, United States
Billings Montana, 59102, United States
Morristown New Jersey, 07960, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Fayetteville North Carolina, 28304, United States
Greenville North Carolina, 27834, United States
Cincinnati Ohio, 45219, United States
Philadelphia Pennsylvania, 19111, United States
Charleston South Carolina, 29425, United States
Richmond Virginia, 23219, United States
Waukesha Wisconsin, 53188, United States
Pilar Buenos Aires, 1629, Argentina
Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires, 1199, Argentina
Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires, 1114, Argentina
Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires, 1431, Argentina
Cordoba , 5016, Argentina
Santa Fe , 3000, Argentina
Camperdown New South Wales, 2050, Australia
Kingswood New South Wales, 2747, Australia
Douglas Queensland, 4814, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Perth Western Australia, 6000, Australia
Langwarrin , 3910, Australia
Sankt Poelten Niederoesterreich, 3100, Austria
Linz Oberoesterreich, 4010, Austria
Salzburg , 5020, Austria
Edegem Antwerpen, 2650, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
La Louvière , 7100, Belgium
Liege , 4000, Belgium
Sint-Niklaas , 9100, Belgium
Turnhout , 2300, Belgium
Curitiba Parana, 80060, Brazil
Botucatu Sao Paulo, 18618, Brazil
Jaú Sao Paulo, 17210, Brazil
São Paulo Sao Paulo, 01509, Brazil
São Paulo Sao Paulo, 04501, Brazil
Rio de Janeiro , 20231, Brazil
Sao Paulo , 01323, Brazil
Sao Paulo , 04039, Brazil
Sao Paulo , 05403, Brazil
Edmonton Alberta, T6G 1, Canada
Victoria British Columbia, V8R 6, Canada
Saint John New Brunswick, E2L 4, Canada
Levis Quebec, G6V 3, Canada
Quebec City Quebec, G1J 1, Canada
Rimouski Quebec, G5L 5, Canada
Beijing Beijing, 10003, China
Beijing Beijing, 10019, China
Fuzhou Fujian, 35000, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51051, China
Shijiazhuang Hebei, 05001, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41000, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, 33000, China
Shenyang Liaoning, 11000, China
Xi'an Shaanxi, 71003, China
Shanghai Shanghai, 20003, China
Tianjin Tianjin, 30022, China
Kunming Yunnan, 65011, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Nanchang , 33002, China
Wuhan , 42002, China
Hradec Kralove , 500 0, Czechia
Praha , 100 3, Czechia
Praha , 128 0, Czechia
Praha , 150 0, Czechia
Herning Midtjylland, 7400, Denmark
Vejle Syddanmark, 7100, Denmark
Clermont Auvergne-Rhone-Alpes, 63100, France
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Rennes Bretagne, 35000, France
Dijon Cote-d Or, 21000, France
Limoges CEDEX 1 Franche-Comte, 87042, France
Nimes CEDEX 9 Gard, 30029, France
Pessac Gironde, 33604, France
Lille Hauts-de-France, 59037, France
Reims CEDEX Marne, 51092, France
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
Nantes Pays-de-la-Loire, 44000, France
Poitiers Poitou-Charentes, 86000, France
Lyon CEDEX 08 Rhone, 69373, France
Caen , 14033, France
Creteil , 94000, France
La Roche Sur Yon , 85000, France
Paris , 75010, France
Paris , 75013, France
Toulouse Cedex 9 , 31059, France
Tubingen Baden-Wuerttemberg, 72076, Germany
Gießen Hessen, 35392, Germany
Leipzig Sachsen, 04103, Germany
Jena Thueringen, 07747, Germany
Bamberg , 96049, Germany
Berlin , 13125, Germany
Bonn , 53127, Germany
Dresden , 01307, Germany
Essen , 45147, Germany
Goettingen , 37075, Germany
Kassel , 34125, Germany
Magdeburg , 39120, Germany
Trier , 54290, Germany
Wuerzburg , 97080, Germany
Athens Attiki, 11527, Greece
Athens Attiki, 11528, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Ioannina , 45500, Greece
Thessaloniki , 54636, Greece
Thessaloniki , 54639, Greece
Szeged Csongrad, 6725, Hungary
Debrecen Hajdu-Bihar, 4032, Hungary
Kaposvár Somogy, 7400, Hungary
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1085, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Be'Er Ya'Akov , 70300, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petakh Tikva , 49414, Israel
Safed , 13100, Israel
San Giovanni Rotondo Foggia, 71013, Italy
Rome Lazio, 00168, Italy
Milan Milano, 20132, Italy
Milan Milano, 20141, Italy
Torino Piemonte, 10126, Italy
Candiolo Torino, 10060, Italy
Alessandria , 15121, Italy
Aviano , 33081, Italy
Bari , 70124, Italy
Brescia , 25123, 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
Kagoshima-shi Kagoshima, 890-8, Japan
Kyoto-shi Kyoto, 606-8, Japan
Tsu-shi Mie, 514-8, Japan
Sendai-shi Miyagi, 98085, Japan
Matsumoto-shi Nagano, 390-8, Japan
Okayama-shi Okayama, 700-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seongnam Gyeonggido, 13620, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49201, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41931, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Hoorn Nh Noord-Holland, 1624 , Netherlands
Dordrecht Zuid-Holland, 3318 , Netherlands
Amsterdam , 1091 , Netherlands
Breda , 4818 , Netherlands
Deventer , 7416 , Netherlands
Enschede , 7512 , Netherlands
Goes , 4462 , Netherlands
Groningen , 9713 , Netherlands
Leiden , 2333 , Netherlands
Nieuwegein , 3435 , Netherlands
Nijmegen , 6532 , Netherlands
Rotterdam , 3045 , Netherlands
Papatoetoe Auckland, 2025, New Zealand
Takapuna Auckland, 0622, New Zealand
Palmerston North Manawatu-Wanganui, 4442, New Zealand
Krakow Malopolskie, 30-51, Poland
Gdynia Pomorskie, 81-51, Poland
Kielce Swietokrzyskie, 25-73, Poland
Pila Wielkopolskie, 64-92, Poland
Skorzewo Wielkopolskie, 60-18, Poland
Manati , 00674, Puerto Rico
Rio Piedras , 00935, Puerto Rico
San Juan , 00918, Puerto Rico
Bratislava , 831 0, Slovakia
Kosice , 040 0, Slovakia
Martin , 036 0, Slovakia
Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0044, South Africa
Cape Town Western Cape, 7925, South Africa
Kuilsrivier Western Cape, 7580, South Africa
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
Santander Cantabria, 39008, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08041, Spain
Caceres , 10003, Spain
Cordoba , 14004, Spain
Madrid , 28027, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Salamanca , 37711, Spain
Sevilla , 41013, Spain
Lulea Norrbottens Lan, 971 8, Sweden
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping , 581 8, Sweden
Aarau Aargau, 5001, Switzerland
St. Gallen Sankt Gallen, 9007, Switzerland
Bellinzona Ticino, 6500, Switzerland
Zurich Zuerich, 8091, Switzerland
Kaohsiung City Kaohsiung, 833, Taiwan
Taichung City , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Ankara , 06620, Turkey
Antalya , 07059, Turkey
Diyarbakir , 21200, Turkey
Istanbul , 34098, Turkey
Istanbul , 34200, Turkey
Istanbul , 34899, Turkey
Izmir , 35040, Turkey
Kocaeli , 41380, Turkey
Samsun , 55200, Turkey
Derby Derbyshire, DE22 , United Kingdom
London London, City Of, E1 2E, United Kingdom
Oxford Oxfordshire, OX3 9, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Birmingham , B15 2, United Kingdom
Canterbury , CT1 3, United Kingdom
Colchester , CO4 5, United Kingdom
Leeds , LS9 7, United Kingdom
Liverpool , L7 8Y, United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
Plymouth , PL6 5, United Kingdom
Portsmouth , PO6 3, United Kingdom
South Shields , NE34 , United Kingdom
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