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Active (not recruiting) Phase 3 NCT06356129

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

Phase 3 – large-scale trial before approval
Conditions: Large B-cell Lymphoma

Sponsor: Celgene

trial.available_in: БГ
Overview
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).
Who can participate
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. 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.
Locations 35
Argentina (1)
Local Institution - 0113
Buenos Aires , Buenos Aires F.D.
Australia (1)
Local Institution - 0357
Gosford , New South Wales
Brazil (1)
Local Institution - 0255
Fortaleza , Ceará
Bulgaria (1)
Local Institution - 0393
Plovdiv
Canada (1)
Local Institution - 0091
Victoria , British Columbia
Chile (1)
Local Institution - 0106
Santiago , Santiago Metropolitan
China (1)
Local Institution - 0195
Beijing , Beijing Municipality
Colombia (1)
Local Institution - 0129
Bogotá , Bogota D.C.
Czech Republic (1)
Local Institution - 0105
Brno , Brno-město
Denmark (1)
Local Institution - 0285
Aarhus , Central Jutland
Finland (1)
Local Institution - 0281
Oulu , North Ostrobothnia
France (1)
Local Institution - 0083
Nice , Alpes-Maritimes
Greece (1)
Local Institution - 0398
Alexandroupoli , Anatolikí Makedonía Kai Thráki
Hungary (1)
Local Institution - 0266
Debrecen , Hajdú-Bihar
India (1)
Local Institution - 0411
Belagavi , Karnataka
Italy (1)
Local Institution - 0495
Ravenna , Emilia-Romagna
Japan (1)
Local Institution - 0371
Nagoya , Aichi-ken
Malaysia (1)
Local Institution - 0453
Lembah Pantai , Kuala Lumpur
Mexico (1)
Local Institution - 0122
Mexico City , DIF
Netherlands (1)
Local Institution - 0500
Leiden , South Holland
New Zealand (1)
Local Institution - 0367
Dunedin , Otago
Norway (1)
Local Institution - 0391
Oslo
Poland (1)
Local Institution - 0388
Skórzewo , Greater Poland Voivodeship
Puerto Rico (1)
Local Institution - 0372
San Juan
Romania (1)
Local Institution - 0381
Bucharest , Bucharest
Saudi Arabia (1)
Local Institution - 0439
Dammam , Eastern Province
Singapore (1)
Local Institution - 0427
Singapore , Central Singapore
Slovakia (1)
Local Institution - 0204
Bratislava
South Korea (1)
Local Institution - 0149
Goyang-si , Kyǒnggi-do
Spain (1)
Local Institution - 0412
A Coruña , A Coruña [La Coruña]
Sweden (1)
Local Institution - 0279
Lund , Skåne Län [se-12]
Taiwan (1)
Local Institution - 0142
Chiayi City , Chiayi
Thailand (1)
Local Institution - 0434
Bangkok , Bangkok
Turkey (1)
Local Institution - 0400
Ankara
United States (1)
Local Institution - 0014
Mobile , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
19.06.2024
Completion date
20.11.2029
Registry ID
NCT06356129
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.