Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)
Interventional
Phase 3
Genmab (Voir sur ClinicalTrials)
février 2023
décembre 2029
05 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:16 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:26 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henri Becquerel /ID# 226103 - 76038 - Rouen - Haute-Corse - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Cote Basque /ID# 249143 - 64100 - Bayonne - Pyrenees-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899 - 85000 - La Roche Sur Yon - Vendee - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille - Hopital Claude Huriez /ID# 226101 - 59037 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| CHRU Nancy - Hopitaux de Brabois /ID# 226102 - 54500 - Vandoeuvre-les-Nancy - Meurthe-et-Moselle - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens-Picardie Site Sud /ID# 238347 - 80054 - Amiens CEDEX 1 - Somme - France | Contact (sur clinicalTrials) | ||||
| Chu Angers /Id# 245931 - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582 - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes, Hotel Dieu -HME /ID# 226125 - 44000 - Nantes - Pays-de-la-Loire - France | Contact (sur clinicalTrials) | ||||
| CHU de Nice - Hôpital Archet 1 /ID# 226127 - 06200 - Nice - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - PONTCHAILLOU /ID# 228207 - 35000 - Rennes - Bretagne - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon /ID# 238345 - 21000 - Dijon - Cote-d Or - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble - Hopital Michallon /ID# 226128 - 38700 - La Tronche - Isere - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Dupuytren 1 /ID# 234235 - 87042 - Limoges CEDEX 1 - Franche-Comte - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - Hopital Saint Eloi /ID# 228191 - 34295 - Montpellier Cedex 5 - Herault - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - La miletrie /ID# 226578 - 86000 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| HCL - Hopital Lyon Sud /ID# 227086 - 69495 - Pierre Benite CEDEX - Rhone - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis /ID# 226126 - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes /ID# 226557 - 13009 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 fresh or paraffin embedded tissue at Screening.
- 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.
- 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 fresh or paraffin embedded tissue at Screening.
- 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.
- 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.