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

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 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-naïve 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of:

-- 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).

Exclusion Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

394

Study ID:

NCT05283720

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 74 Locations for this study

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University of Arizona Cancer Center - North Campus /ID# 242219
Tucson Arizona, 85719, United States
Yale University School of Medicine /ID# 242089
New Haven Connecticut, 06510, United States
Christiana Care Health Service /ID# 242301
Newark Delaware, 19713, United States
Tampa General Hospital /ID# 246748
Tampa Florida, 33606, United States
Emory University /ID# 242153
Atlanta Georgia, 30322, United States
University of Maryland Medical Center /ID# 242218
Baltimore Maryland, 21201, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City Missouri, 64114, United States
Northwell Health - Monter Cancer Center /ID# 245435
Lake Success New York, 11042, United States
Icahn School of Medicine at Mount Sinai /ID# 242123
New York New York, 10029, United States
Novant Health Presbyterian Medical Center /ID# 242148
Charlotte North Carolina, 28204, United States
East Carolina University - Brody School of Medicine /ID# 242506
Greenville North Carolina, 27834, United States
Novant Health Forsyth Medical Center /ID# 242198
Winston-Salem North Carolina, 27103, United States
Thomas Jefferson University /ID# 242077
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center /ID# 242106
Philadelphia Pennsylvania, 19111, United States
Thompson Cancer Survival Ctr /ID# 242150
Knoxville Tennessee, 37916, United States
Joe Arrington Cancer Research /ID# 242226
Lubbock Texas, 79410, United States
Swedish Cancer Institute- First Hill /ID# 242269
Seattle Washington, 98104, United States
Multicare Institute for Research and Innovation /ID# 242127
Tacoma Washington, 98405, United States
Fakultni nemocnice Brno /ID# 242683
Brno , 613 0, Czechia
Fakultni nemocnice Hradec Kralove /ID# 241722
Hradec Kralove , 500 0, Czechia
Fakultni Nemocnice Ostrava /ID# 242684
Ostrava , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 242685
Praha , 128 0, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670
Aarhus Midtjylland, 8200, Denmark
Aalborg University Hospital /ID# 242734
Aalborg Nordjylland, 9000, Denmark
CHU Clermont-Ferrand /ID# 242344
Clermont Auvergne-Rhone-Alpes, 63100, France
CHU de Rennes - PONTCHAILLOU /ID# 242339
Rennes Bretagne, 35000, France
Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336
Paris Ile-de-France, 75010, France
CHRU Nancy - Hopitaux de Brabois /ID# 242342
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
CHRU Lille - Hopital Claude Huriez /ID# 242335
Lille Nord, 59037, France
CHU de Nantes, Hotel Dieu -HME /ID# 242345
Nantes Pays-de-la-Loire, 44000, France
HCL - Hopital Lyon Sud /ID# 242349
Pierre Benite CEDEX Rhone, 69495, France
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 242337
Créteil , 94010, France
Hopital Pitie Salpetriere /ID# 242343
Paris , 75013, France
IUCT Oncopole /ID# 242340
Toulouse Cedex 9 , 31059, France
Universitaetsklinikum Ulm /ID# 244265
Ulm Baden-Wuerttemberg, 89081, Germany
Universitaetsklinikum Leipzig /ID# 245513
Leipzig Sachsen, 04103, Germany
Klinikum Augsburg /ID# 244523
Augsburg , 86156, Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308
Marburg , 35043, Germany
Universitaetsklinikum Regensburg /ID# 244517
Regensburg , 93042, Germany
Universitaetsklinikum Wuerzburg /ID# 245453
Wuerzburg , 97080, Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
Debrecen Hajdu-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
Kaposvár Somogy, 7400, Hungary
Semmelweis Egyetem /ID# 242454
Budapest , 1085, Hungary
Orszagos Onkologiai Intezet /ID# 242458
Budapest , 1122, Hungary
The Chaim Sheba Medical Center /ID# 243010
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 243012
Tel Aviv Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 243013
Jerusalem Yerushalayim, 91120, Israel
Rabin Medical Center /ID# 243014
Haifa , 49414, Israel
Hokkaido University Hospital /ID# 248999
Sapporo-shi Hokkaido, 060-8, Japan
Kyoto University Hospital /ID# 248997
Kyoto-shi Kyoto, 606-8, Japan
National Cancer Center Hospital /ID# 248995
Chuo-ku Tokyo, 104-0, Japan
Seoul National University Bundang Hospital /ID# 242404
Seongnam-si Gyeonggido, 13620, Korea, Republic of
Asan Medical Center /ID# 242400
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Seoul National University Hospital /ID# 242402
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 242401
Seoul , 06351, Korea, Republic of
Duplicate_Erasmus Medisch Centrum /ID# 243315
Rotterdam Zuid-Holland, 3015 , Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen /ID# 243318
Groningen , 9713 , Netherlands
Leids Universitair Medisch Centrum /ID# 243316
Leiden , 2333 , Netherlands
Maastricht Universitair Medisch Centrum /ID# 243317
Maastricht , 6229 , Netherlands
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
Badalona Barcelona, 08916, Spain
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261
Hospitalet de Llobregat Barcelona, 08908, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031
Pamplona Navarra, 31008, Spain
Hospital Universitario Vall d'Hebron /ID# 243260
Barcelona , 08035, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
Madrid , 28027, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 243262
Madrid , 28041, Spain
Hospital Universitario de Salamanca /ID# 243368
Salamanca , 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 243267
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia /ID# 243269
Valencia , 46010, Spain
China Medical University Hospital /ID# 242893
Taichung , 40447, Taiwan
National Cheng Kung University Hospital /ID# 242894
Tainan , 704, Taiwan
Taipei Veterans General Hosp /ID# 242892
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

394

Study ID:

NCT05283720

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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