Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1) (GOLSEEK-1)
Interventional
Phase 3
Celgene (Voir sur ClinicalTrials)
juin 2024
novembre 2029
19 décembre 2024
The purpose of this study is to compare the effectiveness and safety of golcadomide in
combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
(R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants
with previously untreated high-risk large B-cell lymphoma (LBCL).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 24/06/2024 09:40:05 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/12/2024 12:43:59 | 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 | François LEMONNIER, Site 0200 | 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 Hospitalier de la Côte Basque - 64109 - Bayonne - France | Sophie Bernard, Site 0244 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud - 69310 - Pierre-Bénite - Rhône - France | Herve Ghesquieres, Site 0089 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau - 37044 Cedex 9 - Tours - Indre-et-Loire - France | Laurianne Drieu La Rochelle, Site 0079 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Sud Réunion - 97448 - Saint-Pierre - La Réunion - France | Hugo Legendre, Site 0323 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre - 14033 - Caen - France | Gandhi DAMAJ, Site 0315 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu - 44000 - Nantes - Pays-de-la-Loire - France | Thomas Gastinne, Site 0325 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet - 06202 - Nice - Alpes-Maritimes - France | Edmond CHICHE, Site 0083 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Poitiers - 86021 - Poitiers - Vienne - France | Stéphanie Guidez, Site 0306 | Contact (sur clinicalTrials) | |||
| CHRU de Brest - 29609 - Brest - Finistère - France | Adrian Tempescul, Site 0332 | Contact (sur clinicalTrials) | |||
| CHU de Saint-Etienne - 42271 - Saint Priest en Jarez - Loire - France | LUDOVIC FOUILLET, Site 0321 | Contact (sur clinicalTrials) | |||
| Hopital Claude Huriez - CHU de Lille - 59000 - Lille - Nord - France | Franck Morschhauser, Site 0081 | Contact (sur clinicalTrials) | |||
| Hôpital Saint Vincent-de-Paul - 59020 - Lille - Nord-Pas-de-Calais - France | Sandy Amorim, Site 0202 | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - 75010 - Paris - France | Catherine Thieblemont, Site 0077 | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - 33076 - Bordeaux - Aquitaine - France | Fontanet Bijou, Site 0090 | Contact (sur clinicalTrials) | |||
| Institut de cancérologie Strasbourg Europe (ICANS) - 67033 - Strasbourg - Alsace - France | Luc-Matthieu Fornecker, Site 0084 | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - Bouches-du-Rhône - France | Robin NOEL, Site 0087 | Contact (sur clinicalTrials) | |||
| Local Institution - 0074 - 34295 - Montpellier - Languedoc-Roussillon - France | Site 0074 | Contact (sur clinicalTrials) | |||
| Local Institution - 0223 - 38700 - La Tronche - Isère - France | Site 0223 | Contact (sur clinicalTrials) | |||
| Local Institution - 0292 - 21000 - Dijon - Côte-d'Or - France | Site 0292 | Contact (sur clinicalTrials) | |||
| Local Institution - 0324 - 33600 - Pessac - Aquitaine - France | Site 0324 | Contact (sur clinicalTrials) | |||
| Local Institution - 0486 - 25000 - Besançon - Doubs - France | Site 0486 | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Histologically confirmed (per local evaluation) diagnosis of de novo, previously
untreated large B-cell lymphoma (LBCL) according to 2022 world health organization
(WHO) classification including:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal
center B-cell (GCB) and activated B-cell (ABC) types]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2
double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
- International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) >
1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥
7 cm OR IPI ≥ 3.
- Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for
FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter)
disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined
by the Lugano classification.
- Must have Ann Arbor Stage II-IV disease.
- Histologically confirmed (per local evaluation) diagnosis of de novo, previously
untreated large B-cell lymphoma (LBCL) according to 2022 world health organization
(WHO) classification including:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal
center B-cell (GCB) and activated B-cell (ABC) types]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2
double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
- International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) >
1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥
7 cm OR IPI ≥ 3.
- Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for
FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter)
disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined
by the Lugano classification.
- Must have Ann Arbor Stage II-IV disease.
- Any significant medical condition, active infection, laboratory abnormality, or
psychiatric illness that would prevent the participant from participating in the
study.
- Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell
lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma
transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK)
positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
- Documented or suspected central nervous system (CNS) involvement by lymphoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.