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)
Interventional
Phase 3
Celgene (Voir sur ClinicalTrials)
juin 2024
novembre 2029
02 octobre 2025
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 | 10/04/2025 13:11:54 | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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.
Exclusion Criteria:
- 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.