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Набира участници Фаза 3 NCT07215585

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

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

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.
Кой може да участва
Inclusion criteria: * Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment; * Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma; * FDG-avid and measurable disease as per Lugano and Ann Arbor staging; * Stage I bulky (7.5 cm and greater) to Stage IV; * ECOG performance status 0 to 2; * Adequate bone marrow, liver, renal and cardiac function. The above is a summary, other inclusion criteria details may apply. * As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol * Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma). * History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition * Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). * Active or uncontrolled infection * Major cardiac abnormalities * Prior anti-lymphoma therapy except for corticosteroids for symptom control * Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions The above is a summary, other exclusion criteria details may apply.
Интервенции
AZD0486
DRUG
R-mini-CHOP
DRUG
Места на провеждане 62
Австралия (3)
Research Site
Melbourne
Research Site
Nedlands
NOT_YET_RECRUITING
Research Site
Waratah
NOT_YET_RECRUITING
Белгия (6)
Research Site
Antwerp
NOT_YET_RECRUITING
Research Site
Brussels
NOT_YET_RECRUITING
Research Site
Ghent
Research Site
Leuven
Research Site
Roeselare
NOT_YET_RECRUITING
Research Site
Yvoir
Бразилия (2)
Research Site
Porto Alegre
Research Site
São Paulo
Канада (2)
Research Site
Calgary , Alberta
Research Site
Ottawa , Ontario
Китай (18)
Research Site
Beijing
Research Site
Changchun
NOT_YET_RECRUITING
Research Site
Chengdu
NOT_YET_RECRUITING
Research Site
Chongqing
NOT_YET_RECRUITING
Research Site
Fuzhou
NOT_YET_RECRUITING
Research Site
Guangzhou
Research Site
Guangzhou
NOT_YET_RECRUITING
Research Site
Haikou
NOT_YET_RECRUITING
Research Site
Hefei
NOT_YET_RECRUITING
Research Site
Jinan
Research Site
Kunming
NOT_YET_RECRUITING
Research Site
Nanchang
NOT_YET_RECRUITING
Research Site
Nanning
NOT_YET_RECRUITING
Research Site
Nantong
WITHDRAWN
Research Site
Shanghai
Research Site
Shanghai
Research Site
Wuhan
NOT_YET_RECRUITING
Research Site
Xiamen
NOT_YET_RECRUITING
Hong Kong (3)
Research Site
Hong Kong
NOT_YET_RECRUITING
Research Site
Lai Chi Kok
NOT_YET_RECRUITING
Research Site
Shatin
WITHDRAWN
Япония (15)
Research Site
Akashi
NOT_YET_RECRUITING
Research Site
Bunkyō City
Research Site
Himeji-shi
NOT_YET_RECRUITING
Research Site
Kōtoku
Research Site
Kumamoto
NOT_YET_RECRUITING
Research Site
Matsumoto-shi
NOT_YET_RECRUITING
Research Site
Matsuyama
NOT_YET_RECRUITING
Research Site
Meguro-ku
NOT_YET_RECRUITING
Research Site
Nagoya
NOT_YET_RECRUITING
Research Site
Osaka
NOT_YET_RECRUITING
Research Site
Osaka
Research Site
Otaki-Shi
NOT_YET_RECRUITING
Research Site
Sunto-gun
NOT_YET_RECRUITING
Research Site
Yamagata
Research Site
Yokohama
Полша (5)
Research Site
Kielce
NOT_YET_RECRUITING
Research Site
Krakow
Research Site
Lodz
NOT_YET_RECRUITING
Research Site
Lublin
NOT_YET_RECRUITING
Research Site
Wroclaw
NOT_YET_RECRUITING
Южна Корея (2)
Research Site
Seoul
Research Site
Seoul
Турция (2)
Research Site
Ankara
Research Site
Antalya
Великобритания (4)
Research Site
Glasgow, Scotland
NOT_YET_RECRUITING
Research Site
London
Research Site
Newcastle upon Tyne
Research Site
Nottingham
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
65 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
11.11.2025
Крайна дата
28.07.2033
Регистрационен номер
NCT07215585
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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