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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

900

Study ID:

NCT05578976

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 112 Locations for this study

See Locations Near You

Liverpool Hospital /ID# 230072
Liverpool New South Wales, 2170, Australia
Royal Adelaide Hospital /ID# 225683
Adelaide South Australia, 5000, Australia
Perth Blood Institute Ltd /ID# 225679
Nedlands Western Australia, 6009, Australia
Royal Perth Hospital /ID# 226583
Perth Western Australia, 6000, Australia
Klinik Ottakring /ID# 243941
Vienna Wien, 1160, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360
Salzburg , 5020, Austria
CHU UCL Namur - site Godinne /ID# 225742
Godinne Namur, 5530, Belgium
Pôle Hospitalier Jolimont /ID# 225738
La Louvière , 7100, Belgium
Vitaz /Id# 226153
Sint-Niklaas , 9100, Belgium
UMHAT Sveti Georgi /ID# 245780
Plovdiv , 4002, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
Sofia , 1407, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 244615
Sofia , 1431, Bulgaria
SHAT Hematologic Diseases /ID# 250102
Sofia , 1756, Bulgaria
Clinical Hospital Dubrava /ID# 251809
Zagreb Grad Zagreb, 10000, Croatia
Klinicka bolnica Merkur /ID# 252481
Zagreb Grad Zagreb, 10000, Croatia
Klinicki bolnicki centar Split /ID# 250729
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Opca bolnica Dr. Josip Bencevic /ID# 251812
Slavonski Brod , 35000, Croatia
Fakultni nemocnice Hradec Kralove /ID# 225955
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava /ID# 225957
Ostrava , 708 5, Czechia
Zealand University Hospital, Roskilde /ID# 226597
Roskilde Sjælland, 4000, Denmark
Odense University Hospital /ID# 226593
Odense C Syddanmark, 5000, Denmark
Sygehus Lillebalt, Vejle /ID# 226592
Vejle Syddanmark, 7100, Denmark
HCL - Hopital Lyon Sud /ID# 227086
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
CHU de Rennes - PONTCHAILLOU /ID# 228207
Rennes Bretagne, 35000, France
CHU Limoges - Dupuytren 1 /ID# 234235
Limoges CEDEX 1 Franche-Comte, 87042, France
CHRU Lille - Hopital Claude Huriez /ID# 226101
Lille Hauts-de-France, 59037, France
CHU Montpellier - Hôpital Saint Eloi /ID# 228191
Montpellier Cedex 5 Herault, 34295, France
CHU de Nantes, Hotel Dieu -HME /ID# 226125
Nantes Pays-de-la-Loire, 44000, France
Centre Hospitalier de la Cote Basque /ID# 249143
Bayonne Pyrenees-Atlantiques, 64100, France
Chu Angers /Id# 245931
Angers , 49933, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582
Caen , 14033, France
Hopital Henri Mondor /ID# 226560
Creteil , 94000, France
CHU Grenoble - Hopital Michallon /ID# 226128
La Tronche , 38700, France
AP-HP - Hopital Saint-Louis /ID# 226126
Paris , 75010, France
General Hospital of Athens Laiko /ID# 225399
Athens Attiki, 11527, Greece
Alexandra General Hospital /ID# 225402
Athens Attiki, 11528, Greece
University General Hospital Attikon /ID# 225401
Athens Attiki, 12462, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
Athens , 10676, Greece
University General Hospital of Ioannina /ID# 225400
Ioannina , 45500, Greece
General University Hospital of Thessaloniki AXEPA /ID# 225398
Thessaloniki , 54636, Greece
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 245938
Kaposvár Somogy, 7400, Hungary
Markusovszky Egyetemi Oktatokorhaz /ID# 226846
Szombathely Vas, 9700, Hungary
Semmelweis Egyetem /ID# 227239
Budapest , 1085, Hungary
Orszagos Onkologiai Intezet /ID# 227294
Budapest , 1122, Hungary
Tolna Megyei Balassa Janos Korhaz /ID# 250063
Szekszard , 7100, Hungary
Assuta Tel Aviv Medical Center /ID# 226066
Tel Aviv HaMerkaz, 69710, Israel
The Chaim Sheba Medical Center /ID# 225600
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 225891
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah /ID# 225614
Jerusalem , 91120, Israel
Meir Medical Center /ID# 225612
Kfar Saba , 44281, Israel
Rabin Medical Center /ID# 225862
Petakh Tikva , 49414, Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542
Alessandria , 15121, Italy
ASST Spedali civili di Brescia /ID# 225549
Brescia , 25123, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 225543
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
Novara , 28100, Italy
NHO Nagoya Medical Center /ID# 230677
Nagoya-shi Aichi, 460-0, Japan
Aichi Cancer Center Hospital /ID# 226090
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East /ID# 250151
Kashiwa-shi Chiba, 277-8, Japan
Matsuyama Red Cross Hospital /ID# 251068
Matsuyama-shi Ehime, 790-8, Japan
National Hospital Organization Kyushu Cancer Center /ID# 251622
Fukuoka-shi Fukuoka, 811-1, Japan
Fukushima Medical University Hospital /ID# 250869
Fukushima-shi Fukushima, 960-1, Japan
Hokkaido University Hospital /ID# 250149
Sapporo-shi Hokkaido, 060-8, Japan
Kobe City Medical Center General Hospital /ID# 250597
Kobe-shi Hyogo, 650-0, Japan
Kanazawa University Hospital /ID# 251770
Kanazawa-shi Ishikawa, 920-8, Japan
Kagoshima University Hospital /ID# 250163
Kagoshima-shi Kagoshima, 890-8, Japan
Tokai University Hospital /ID# 251281
Isehara-shi Kanagawa, 259-1, Japan
Tohoku University Hospital /ID# 250150
Sendai-shi Miyagi, 98085, Japan
Okayama University Hospital /ID# 250161
Okayama-shi Okayama, 700-8, Japan
Kindai University Hospital /ID# 250160
Osakasayama-shi Osaka, 589-8, Japan
Osaka University Hospital /ID# 251283
Suita-shi Osaka, 565-0, Japan
The Cancer Institute Hospital Of JFCR /ID# 230269
Koto-ku Tokyo, 135-8, Japan
Yamagata University Hospital /ID# 230003
Yamagata-shi Yamagata, 990-9, Japan
Seoul National University Bundang Hospital /ID# 225763
Seongnam Gyeonggido, 13620, Korea, Republic of
Inje University Busan Paik Hospital /ID# 232262
Busan , 47392, Korea, Republic of
Dong-A University Hospital /ID# 228451
Busan , 49201, Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 232264
Daegu , 41931, Korea, Republic of
Jeonbuk National University Hospital /ID# 232263
Jeonju , 54907, Korea, Republic of
Seoul National University Hospital /ID# 225760
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 225759
Seoul , 06351, Korea, Republic of
Ulsan University Hospital /ID# 226971
Ulsan , 44033, Korea, Republic of
Flevoziekenhuis /ID# 229606
Almere Flevoland, 1315 , Netherlands
Gelre Ziekenhuizen /ID# 229762
Apeldoorn Gelderland, 7334 , Netherlands
Tergooi /ID# 229772
Hilversum Noord-Holland, 1213 , Netherlands
Albert Schweitzer Ziekenhuis /ID# 229560
Dordrecht Zuid-Holland, 3318 , Netherlands
Noordwest Ziekenhuisgroep /ID# 230613
Alkmaar , 1815 , Netherlands
Vrije Universiteit Medisch Centrum /ID# 225608
Amsterdam , 1081 , Netherlands
Onze Lieve Vrouwe Gasthuis /ID# 229761
Amsterdam , 1091 , Netherlands
Haaglanden Medisch Centrum /ID# 229686
Den Haag , 2512 , Netherlands
Deventer Ziekenhuis /ID# 229937
Deventer , 7416 , Netherlands
Catharina Ziekenhuis /ID# 230465
Eindhoven , 5623 , Netherlands
Medisch Centrum Leeuwarden /ID# 225605
Leeuwarden , 8934 , Netherlands
St. Antonius Ziekenhuis /ID# 229901
Nieuwegein , 3435 , Netherlands
Jeroen Bosch Ziekenhuis /ID# 229765
S Hertogenbosch , 5223 , Netherlands
Elisabeth Tweesteden Ziekenhuis /ID# 229773
Tilburg , 5022 , Netherlands
North Shore Hospital /ID# 250992
Takapuna Auckland, 0622, New Zealand
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
Slupsk Pomorskie, 76-20, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986
Kielce Swietokrzyskie, 25-73, Poland
SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
Olsztyn Warminsko-mazurskie, 10-22, Poland
ARS-MEDICAL Sp. z o.o. /ID# 225848
Pila Wielkopolskie, 64-92, Poland
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809
Pamplona Navarra, 31008, Spain
Hospital Parc de Salut del Mar /ID# 225810
Barcelona , 08003, Spain
Hospital Universitario Vall d'Hebron /ID# 225811
Barcelona , 08035, Spain
Hospital Santa Creu i Sant Pau /ID# 225813
Barcelona , 08041, Spain
Hospital Universitario Reina Sofia /ID# 225806
Cordoba , 14004, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
Madrid , 28027, Spain
Hospital Universitario Infanta Leonor /ID# 225816
Madrid , 28031, Spain
Hospital Universitario Ramon y Cajal /ID# 241750
Madrid , 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 225815
Madrid , 28041, Spain
Hospital Clinico Universitario de Valencia /ID# 225818
Valencia , 46010, Spain
Sodra Alvsborgs sjukhus /ID# 228885
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping University Hospital /ID# 233521
Linkoping , 581 8, Sweden
Kantonsspital Aarau AG /ID# 229112
Aarau Aargau, 5001, Switzerland
Spital Thun /ID# 229499
Thun Bern, 3600, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 226670
Kaohsiung City Kaohsiung, 833, Taiwan
China Medical University Hospital /ID# 226188
Taichung , 40447, Taiwan
National Cheng Kung University Hospital /ID# 226671
Tainan , 704, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

900

Study ID:

NCT05578976

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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