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
NCT ID: NCT05283720
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
496 participants
INTERVENTIONAL
2022-06-14
2032-11-30
Brief Summary
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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 496 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, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:
1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1: Dose Escalation
Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of epcoritamab in combination with lenalidomide in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Arm 2: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of epcoritamab in combination with ibrutinib and lenalidomide in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Ibrutinib
Oral; Capsule
Arm 3: Dose Escalation
Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Rituximab
Intravenous (IV); Injection
Cyclophosphamide
IV; Injection
Doxorubicin Hydrochloride [HCl]
IV; Injection
Prednisone
Oral; Tablet
Polatuzumab Vedotin
IV; Injection
Arm 4: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
CC-99282
Oral; Capsule
Arm 5: Dose Escalation
Participants with R/R follicular lymphoma (FL) will receive escalating doses of epcoritamab in combination with CC-99282 in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
CC-99282
Oral; Capsule
Arm 6A: Dose Escalation
Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of epcoritamab in combination with ibrutinib in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Ibrutinib
Oral; Capsule
Arm 1: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with lenalidomide in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Arm 2: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Ibrutinib
Oral; Capsule
Arm 3: Dose Expansion
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP) in 21 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Rituximab
Intravenous (IV); Injection
Cyclophosphamide
IV; Injection
Doxorubicin Hydrochloride [HCl]
IV; Injection
Prednisone
Oral; Tablet
Polatuzumab Vedotin
IV; Injection
Arm 3B: Dose Expansion
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin hydrochloride (HCl), and prednisone (pola-R-CHP), in 21 day cycles,until unacceptable toxicity, withdrawal of consent, or completion of treatment.
Epcoritamab
Subcutaneous Injection (SC)
Rituximab
Intravenous (IV); Injection
Cyclophosphamide
IV; Injection
Doxorubicin Hydrochloride [HCl]
IV; Injection
Prednisone
Oral; Tablet
Polatuzumab Vedotin
IV; Injection
Arm 4: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
CC-99282
Oral; Capsule
Arm 5: Dose Expansion
Participants with R/R FL will receive the recommended dose of epcoritamab in combination with CC-99282 in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
CC-99282
Oral; Capsule
Arm 6: Dose Expansion
Participants with R/R MCL will receive the recommended dose of epcoritamab in combination with ibrutinib in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Ibrutinib
Oral; Capsule
Interventions
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Epcoritamab
Subcutaneous Injection (SC)
Lenalidomide
Oral; Capsule
Ibrutinib
Oral; Capsule
Rituximab
Intravenous (IV); Injection
Cyclophosphamide
IV; Injection
Doxorubicin Hydrochloride [HCl]
IV; Injection
Prednisone
Oral; Tablet
Polatuzumab Vedotin
IV; Injection
CC-99282
Oral; Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\-- 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, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A 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
* Toxicities from prior anticancer therapy that have 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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The 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
Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, United States
University of Maryland, Baltimore /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 Hospital /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 /ID# 242269
Seattle, Washington, United States
MultiCare Institute for Research & Innovation /ID# 242127
Tacoma, Washington, United States
Fakultní Nemocnice Brno - Jihlavská /ID# 242683
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 241722
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 242684
Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni Nemocnice v Praze /ID# 242685
Prague, Praha 17, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670
Aarhus, Central Jutland, Denmark
Aalborg University Hospital /ID# 242734
Aalborg, North Denmark, Denmark
CHU Clermont-Ferrand /ID# 242344
Clermont, Auvergne-Rhône-Alpes, France
CHU de Rennes - PONTCHAILLOU /ID# 242339
Rennes, Brittany Region, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 242342
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 242335
Lille, Nord, France
IUCT Oncopole /ID# 242340
Toulouse, Occitanie, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 242337
Créteil, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 242345
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 242349
Pierre-Bénite, Rhone, France
Hôpital Saint-Louis /ID# 242336
Paris, , France
Hopital Pitie Salpetriere /ID# 242343
Paris, Île-de-France Region, France
Universitaetsklinikum Ulm /ID# 244265
Ulm, Baden-Wurttemberg, Germany
Klinikum Augsburg /ID# 244523
Augsburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg /ID# 245453
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg /ID# 245308
Marburg, Hesse, Germany
Universitaetsklinikum Leipzig /ID# 245513
Leipzig, Saxony, Germany
Universitaetsklinikum Regensburg /ID# 244517
Regensburg, , Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
Debrecen, Hajdú-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
Kaposvár, Somogy County, Hungary
Semmelweis Egyetem /ID# 242454
Budapest, , Hungary
Orszagos Onkologiai Intezet /ID# 242458
Budapest, , Hungary
Hadassah Medical Center-Hebrew University /ID# 243013
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 243010
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243012
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center. /ID# 243014
Petah Tikva, , Israel
Hokkaido University Hospital /ID# 248999
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 248997
Kyoto, Kyoto, Japan
National Cancer Center Hospital /ID# 248995
Chuo-ku, Tokyo, Japan
Maastricht Universitair Medisch Centrum /ID# 243317
Maastricht, Limburg, Netherlands
Vrije Universiteit Medisch Centrum /ID# 243319
Amsterdam, North Holland, Netherlands
Leids Universitair Medisch Centrum /ID# 243316
Leiden, South Holland, Netherlands
Duplicate_Erasmus Medisch Centrum /ID# 243315
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 243318
Groningen, , Netherlands
Seoul National University Bundang Hospital /ID# 242404
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 242402
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 242400
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 242401
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
Seoul, Seoul Teugbyeolsi, South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
Badalona, Barcelona, Spain
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 243261
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 245031
Pamplona, Navarre, Spain
Hospital Universitario Vall de 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
Seville, , 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
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2023-505347-38
Identifier Type: OTHER
Identifier Source: secondary_id
M22-132
Identifier Type: -
Identifier Source: org_study_id
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