Non Hodgkin Lymphoma Clinical Trial
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 132 adult participants with NHL will be enrolled in 100 sites globally.
In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2 and 21- day cycles for arm 3.
Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL.
Arm 3: SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naÃ¯ve DLBCL.
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.
-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
DLBCL, not otherwise specified (NOS).
High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
Follicular lymphoma (FL) Grade 3B. OR
FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or polymerase chain reaction (PCR).
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms 6 and 7 where ECOG performance status must be 0-1.
Must have 1 or more measurable disease sites:
A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).
Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
Toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
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There are 66 Locations for this study
Tucson Arizona, 85719, United States
New Haven Connecticut, 06510, United States
Newark Delaware, 19713, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21201, United States
Kansas City Missouri, 64114, United States
Lake Success New York, 11042, United States
New York New York, 10029, United States
Charlotte North Carolina, 28204, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27103, United States
Philadelphia Pennsylvania, 19111, United States
Knoxville Tennessee, 37916, United States
Lubbock Texas, 79410, United States
Seattle Washington, 98104, United States
Tacoma Washington, 98405, United States
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Praha , 128 0, Czechia
Aarhus N Midtjylland, 8200, Denmark
Clermont Auvergne-Rhone-Alpes, 63100, France
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Rennes Bretagne, 35000, France
Lille Hauts-de-France, 59037, France
Paris Ile-de-France, 75010, France
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
Nantes Pays-de-la-Loire, 44000, France
Creteil , 94000, France
Paris , 75013, France
Toulouse Cedex 9 , 31059, France
Ulm Baden-Wuerttemberg, 89081, Germany
Debrecen Hajdu-Bihar, 4032, Hungary
Kaposvár Somogy, 7400, Hungary
Budapest , 1085, Hungary
Budapest , 1122, Hungary
Haifa H_efa, 49414, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91120, Israel
Sapporo-shi Hokkaido, 060-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Seongnam Gyeonggido, 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Rotterdam Zuid-Holland, 3015 , Netherlands
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Leiden , 2333 , Netherlands
Maastricht , 6229 , Netherlands
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Salamanca , 37711, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 11217, Taiwan
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