Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
Study ID: NCT05283720
Conditions
Study Description
Brief Summary: 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 394 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 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL. 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center - North Campus /ID# 242219, Tucson, Arizona, United States
Yale University School of Medicine /ID# 242089, New Haven, Connecticut, United States
Christiana Care Health Service /ID# 242301, Newark, Delaware, United States
Tampa General Hospital /ID# 246748, Tampa, Florida, United States
Emory University /ID# 242153, Atlanta, Georgia, United States
University of Maryland Medical Center /ID# 242218, Baltimore, Maryland, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144, Kansas City, Missouri, United States
Northwell Health - Monter Cancer Center /ID# 245435, Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 242123, New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 242148, Charlotte, North Carolina, United States
East Carolina University - Brody School of Medicine /ID# 242506, Greenville, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 242198, Winston-Salem, North Carolina, United States
Thomas Jefferson University /ID# 242077, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center /ID# 242106, Philadelphia, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 242150, Knoxville, Tennessee, United States
Joe Arrington Cancer Research /ID# 242226, Lubbock, Texas, United States
Swedish Cancer Institute- First Hill /ID# 242269, Seattle, Washington, United States
Multicare Institute for Research and Innovation /ID# 242127, Tacoma, Washington, United States
Fakultni nemocnice Brno /ID# 242683, Brno, , Czechia
Fakultni nemocnice Hradec Kralove /ID# 241722, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava /ID# 242684, Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 242685, Praha, , Czechia
Aarhus Universitetshospital - Skejby /ID# 242670, Aarhus, Midtjylland, Denmark
Aalborg University Hospital /ID# 242734, Aalborg, Nordjylland, Denmark
CHU Clermont-Ferrand /ID# 242344, Clermont, Auvergne-Rhone-Alpes, France
CHU de Rennes - PONTCHAILLOU /ID# 242339, Rennes, Bretagne, France
Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336, Paris, Ile-de-France, France
CHRU Nancy - Hopitaux de Brabois /ID# 242342, Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 242335, Lille, Nord, France
CHU de Nantes, Hotel Dieu -HME /ID# 242345, Nantes, Pays-de-la-Loire, France
HCL - Hopital Lyon Sud /ID# 242349, Pierre Benite CEDEX, Rhone, France
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 242337, Créteil, , France
Hopital Pitie Salpetriere /ID# 242343, Paris, , France
IUCT Oncopole /ID# 242340, Toulouse Cedex 9, , France
Universitaetsklinikum Ulm /ID# 244265, Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Leipzig /ID# 245513, Leipzig, Sachsen, Germany
Klinikum Augsburg /ID# 244523, Augsburg, , Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308, Marburg, , Germany
Universitaetsklinikum Regensburg /ID# 244517, Regensburg, , Germany
Universitaetsklinikum Wuerzburg /ID# 245453, Wuerzburg, , Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 242450, Debrecen, Hajdu-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935, Kaposvár, Somogy, Hungary
Semmelweis Egyetem /ID# 242454, Budapest, , Hungary
Orszagos Onkologiai Intezet /ID# 242458, Budapest, , Hungary
The Chaim Sheba Medical Center /ID# 243010, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243012, Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 243013, Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 243014, Haifa, , Israel
Hokkaido University Hospital /ID# 248999, Sapporo-shi, Hokkaido, Japan
Kyoto University Hospital /ID# 248997, Kyoto-shi, Kyoto, Japan
National Cancer Center Hospital /ID# 248995, Chuo-ku, Tokyo, Japan
Seoul National University Bundang Hospital /ID# 242404, Seongnam-si, Gyeonggido, Korea, Republic of
Asan Medical Center /ID# 242400, Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 242402, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 242401, Seoul, , Korea, Republic of
Duplicate_Erasmus Medisch Centrum /ID# 243315, Rotterdam, Zuid-Holland, Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen /ID# 243318, Groningen, , Netherlands
Leids Universitair Medisch Centrum /ID# 243316, Leiden, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 243317, Maastricht, , Netherlands
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265, Badalona, Barcelona, Spain
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261, Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031, Pamplona, Navarra, Spain
Hospital Universitario Vall d'Hebron /ID# 243260, Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264, Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 243262, Madrid, , Spain
Hospital Universitario de Salamanca /ID# 243368, Salamanca, , Spain
Hospital Universitario Virgen del Rocio /ID# 243267, Sevilla, , Spain
Hospital Clinico Universitario de Valencia /ID# 243269, Valencia, , Spain
China Medical University Hospital /ID# 242893, Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 242894, Tainan, , Taiwan
Taipei Veterans General Hosp /ID# 242892, Taipei, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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