Non Hodgkin Lymphoma Clinical Trial
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
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.
Key Inclusion Criteria:
≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
Histologically confirmed diagnosis of MCL
No prior systemic treatments for MCL
Measurable disease by CT/MRI
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate marrow and organ function
Key Exclusion Criteria:
Known central nervous system involvement by lymphoma
Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
Clinically significant cardiovascular disease
History of severe bleeding disorder
Unable to swallow capsules or disease significantly affecting gastrointestinal function
Active fungal, bacterial and/or viral infection requiring systemic therapy
Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 16 Locations for this study
Nagoyashi Aichi, 460-0, Japan
Toyohashi Aichi, 441-8, Japan
Chibashi Chiba, 260-8, Japan
Kurume Fukuoka, 830-0, Japan
Hiroshimashi Hiroshima, 730-8, Japan
Yokohamashi Kanagawa, 241-8, Japan
Yokohama Kanagawa, 24085, Japan
Kumamotoshi Kumamoto, 860-0, Japan
Sendaishi Miyagi, 980-8, Japan
Kurashikishi Okayama, 710-8, Japan
Osakashi Osaka, 543-8, Japan
Chuoku Tokyo, 104-0, Japan
Kyoto , 602-8, Japan
Okayama , 701-1, Japan
Osaka , 545-8, Japan
Tokyo , 113-8, Japan
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