Last updated 3 days ago
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma
850 patients around the world
Available in Puerto Rico, Spain, Colombia, Chile, Brazil, Argentina, Mexico, United States
Celgene
4Research sites
850Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Large B-cell lymphoma
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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 rearrangementsiii) High-grade B-cell lymphoma, not otherwise specifiediv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)v) Epstein-Barr virus + DLBCLInternational 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 ≥ 3Measurable 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 classificationMust 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 studyAny other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to a-BCL, Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphomaDocumented or suspected central nervous system (CNS) involvement by lymphoma
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Hospital Alemán
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Privado de Córdoba
Recruiting
StudyGOLSEEK-1
SponsorCelgene
Conditions
Large B-cell lymphoma
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06356129
