Non Hodgkin Lymphoma Clinical Trial

Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

510

Study ID:

NCT04002297

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 16 Locations for this study

See Locations Near You

National Hospital Organization Nagoya Medical Center
Nagoyashi Aichi, 460-0, Japan
Toyohashi Municipal Hospital
Toyohashi Aichi, 441-8, Japan
Chiba Cancer Center
Chibashi Chiba, 260-8, Japan
Kurume University Hospital
Kurume Fukuoka, 830-0, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshimashi Hiroshima, 730-8, Japan
Kanagawa Cancer Center
Yokohamashi Kanagawa, 241-8, Japan
Yokohama Municipal Citizens Hospital
Yokohama Kanagawa, 24085, Japan
National Hospital Organization Kumamoto Medical Center
Kumamotoshi Kumamoto, 860-0, Japan
Tohoku University Hospital
Sendaishi Miyagi, 980-8, Japan
Kurashiki Central Hospital
Kurashikishi Okayama, 710-8, Japan
Osaka Red Cross Hospital
Osakashi Osaka, 543-8, Japan
National Cancer Center Hospital
Chuoku Tokyo, 104-0, Japan
University Hospital, Kyoto Prefectural Univ of Medicine
Kyoto , 602-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Tokyo Medical and Dental University Hospital
Tokyo , 113-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

510

Study ID:

NCT04002297

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

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