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Активно (без набиране) Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Large B-cell Lymphoma

Спонсор: Celgene

Налично на: БГ
Обобщение
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).
Кой може да участва
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.
Места на провеждане 35
Argentina (1)
Local Institution - 0113
Buenos Aires , Buenos Aires F.D.
Австралия (1)
Local Institution - 0357
Gosford , New South Wales
Бразилия (1)
Local Institution - 0255
Fortaleza , Ceará
България (1)
Local Institution - 0393
Plovdiv
Канада (1)
Local Institution - 0091
Victoria , British Columbia
Chile (1)
Local Institution - 0106
Santiago , Santiago Metropolitan
Китай (1)
Local Institution - 0195
Beijing , Beijing Municipality
Colombia (1)
Local Institution - 0129
Bogotá , Bogota D.C.
Чехия (1)
Local Institution - 0105
Brno , Brno-město
Дания (1)
Local Institution - 0285
Aarhus , Central Jutland
Финландия (1)
Local Institution - 0281
Oulu , North Ostrobothnia
Франция (1)
Local Institution - 0083
Nice , Alpes-Maritimes
Гърция (1)
Local Institution - 0398
Alexandroupoli , Anatolikí Makedonía Kai Thráki
Унгария (1)
Local Institution - 0266
Debrecen , Hajdú-Bihar
Индия (1)
Local Institution - 0411
Belagavi , Karnataka
Италия (1)
Local Institution - 0495
Ravenna , Emilia-Romagna
Япония (1)
Local Institution - 0371
Nagoya , Aichi-ken
Malaysia (1)
Local Institution - 0453
Lembah Pantai , Kuala Lumpur
Mexico (1)
Local Institution - 0122
Mexico City , DIF
Нидерландия (1)
Local Institution - 0500
Leiden , South Holland
New Zealand (1)
Local Institution - 0367
Dunedin , Otago
Норвегия (1)
Local Institution - 0391
Oslo
Полша (1)
Local Institution - 0388
Skórzewo , Greater Poland Voivodeship
Puerto Rico (1)
Local Institution - 0372
San Juan
Румъния (1)
Local Institution - 0381
Bucharest , Bucharest
Saudi Arabia (1)
Local Institution - 0439
Dammam , Eastern Province
Сингапур (1)
Local Institution - 0427
Singapore , Central Singapore
Словакия (1)
Local Institution - 0204
Bratislava
Южна Корея (1)
Local Institution - 0149
Goyang-si , Kyǒnggi-do
Испания (1)
Local Institution - 0412
A Coruña , A Coruña [La Coruña]
Швеция (1)
Local Institution - 0279
Lund , Skåne Län [se-12]
Taiwan (1)
Local Institution - 0142
Chiayi City , Chiayi
Тайланд (1)
Local Institution - 0434
Bangkok , Bangkok
Турция (1)
Local Institution - 0400
Ankara
САЩ (1)
Local Institution - 0014
Mobile , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
19.06.2024
Крайна дата
20.11.2029
Регистрационен номер
NCT06356129
Източник
anzctr
Запитване за медицински туризъм

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