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Active (not recruiting) Phase 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

Phase 3 – large-scale trial before approval
Conditions: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Sponsor: BeiGene

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 20
Australia (1)
Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
Az Sint Jan Brugge
Bruges
Canada (1)
The Ottawa Hospital
Ottawa , Ontario
China (1)
Peking University Peoples Hospital
Beijing , Beijing Municipality
France (1)
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Germany (1)
Uniklinik Koln (Aor)
Cologne
Ireland (1)
Cork University Hospital
Cork
Italy (1)
Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo
Alessandria
Japan (1)
National Hospital Organization Nagoya Medical Center
Nagoya , Aichi-ken
Netherlands (1)
Admiraal de Ruijter Ziekenhuis
Goes
New Zealand (1)
Christchurch Hospital (Canterbury Health Laboratories)
Christchurch
Poland (1)
Szpital Uniwersytecki Nr Im Dr Jana Biziela
Bydgoszcz
Romania (1)
Institutul Clinic Fundeni
Bucharest
Russia (1)
Clinical Hospital, Sp Botkin
Moscow , Moscow
Spain (1)
Hospital Universitario Vall Dhebron
Barcelona
Taiwan (1)
National Cheng Kung University Hospital
Tainan
Turkey (1)
Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara
Ukraine (1)
Cherkasy Regional Oncology Dispensary
Cherkasy
United Kingdom (1)
Aneurin Bevan University Health Board
Abergavenny
United States (1)
Chao Family Comprehensive Cancer Center
Orange , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
60 Years
Healthy volunteers
No
Start date
20.08.2019
Completion date
01.12.2027
Registry ID
NCT04002297
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.