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 112 Locations for this study
Liverpool New South Wales, 2170, Australia
Adelaide South Australia, 5000, Australia
Nedlands Western Australia, 6009, Australia
Perth Western Australia, 6000, Australia
Vienna Wien, 1160, Austria
Salzburg , 5020, Austria
Godinne Namur, 5530, Belgium
La Louvière , 7100, Belgium
Sint-Niklaas , 9100, Belgium
Plovdiv , 4002, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1756, Bulgaria
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Slavonski Brod , 35000, Croatia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Roskilde Sjælland, 4000, Denmark
Odense C Syddanmark, 5000, Denmark
Vejle Syddanmark, 7100, Denmark
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Rennes Bretagne, 35000, France
Limoges CEDEX 1 Franche-Comte, 87042, France
Lille Hauts-de-France, 59037, France
Montpellier Cedex 5 Herault, 34295, France
Nantes Pays-de-la-Loire, 44000, France
Bayonne Pyrenees-Atlantiques, 64100, France
Angers , 49933, France
Caen , 14033, France
Creteil , 94000, France
La Tronche , 38700, France
Paris , 75010, France
Athens Attiki, 11527, Greece
Athens Attiki, 11528, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Ioannina , 45500, Greece
Thessaloniki , 54636, Greece
Kaposvár Somogy, 7400, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1085, Hungary
Budapest , 1122, Hungary
Szekszard , 7100, Hungary
Tel Aviv HaMerkaz, 69710, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petakh Tikva , 49414, Israel
Alessandria , 15121, Italy
Brescia , 25123, Italy
Napoli , 80131, Italy
Novara , 28100, 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
Fukushima-shi Fukushima, 960-1, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, 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
Koto-ku Tokyo, 135-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seongnam Gyeonggido, 13620, 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
Ulsan , 44033, Korea, Republic of
Almere Flevoland, 1315 , Netherlands
Apeldoorn Gelderland, 7334 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Dordrecht Zuid-Holland, 3318 , Netherlands
Alkmaar , 1815 , Netherlands
Amsterdam , 1081 , Netherlands
Amsterdam , 1091 , Netherlands
Den Haag , 2512 , Netherlands
Deventer , 7416 , Netherlands
Eindhoven , 5623 , Netherlands
Leeuwarden , 8934 , Netherlands
Nieuwegein , 3435 , Netherlands
S Hertogenbosch , 5223 , Netherlands
Tilburg , 5022 , Netherlands
Takapuna Auckland, 0622, New Zealand
Slupsk Pomorskie, 76-20, Poland
Kielce Swietokrzyskie, 25-73, Poland
Olsztyn Warminsko-mazurskie, 10-22, Poland
Pila Wielkopolskie, 64-92, Poland
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Cordoba , 14004, Spain
Madrid , 28027, Spain
Madrid , 28031, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping , 581 8, Sweden
Aarau Aargau, 5001, Switzerland
Thun Bern, 3600, Switzerland
Kaohsiung City Kaohsiung, 833, Taiwan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
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