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Активно (без набиране) Фаза 3 NCT04002297

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Фаза 3 – широко изпитване преди одобрение
Заболявания: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Спонсор: BeiGene

Налично на: БГ
Обобщение
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
Кой може да участва
Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and \<70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 20
Австралия (1)
Canberra Hospital
Garran , Australian Capital Territory
Белгия (1)
Az Sint Jan Brugge
Bruges
Канада (1)
The Ottawa Hospital
Ottawa , Ontario
Китай (1)
Peking University Peoples Hospital
Beijing , Beijing Municipality
Франция (1)
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Германия (1)
Uniklinik Koln (Aor)
Cologne
Ireland (1)
Cork University Hospital
Cork
Италия (1)
Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo
Alessandria
Япония (1)
National Hospital Organization Nagoya Medical Center
Nagoya , Aichi-ken
Нидерландия (1)
Admiraal de Ruijter Ziekenhuis
Goes
New Zealand (1)
Christchurch Hospital (Canterbury Health Laboratories)
Christchurch
Полша (1)
Szpital Uniwersytecki Nr Im Dr Jana Biziela
Bydgoszcz
Румъния (1)
Institutul Clinic Fundeni
Bucharest
Russia (1)
Clinical Hospital, Sp Botkin
Moscow , Moscow
Испания (1)
Hospital Universitario Vall Dhebron
Barcelona
Taiwan (1)
National Cheng Kung University Hospital
Tainan
Турция (1)
Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara
Ukraine (1)
Cherkasy Regional Oncology Dispensary
Cherkasy
Великобритания (1)
Aneurin Bevan University Health Board
Abergavenny
САЩ (1)
Chao Family Comprehensive Cancer Center
Orange , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
60 Years
Здрави доброволци
Не
Начална дата
20.08.2019
Крайна дата
01.12.2027
Регистрационен номер
NCT04002297
Източник
anzctr
Запитване за медицински туризъм

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