Trial purpose
Cancer treatment
Tumor type
Haematological
Age
65+
Clinical summary
Summary
Eligible patients will be randomised to receive zanubrutinib (a targeted therapy) OR bendamustine (chemotherapy) in combination with rituximab for the treatment of their cancer. Zanubrutinib will be administered as two 80 mg capsules by mouth twice a day; bendamustine will be administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6; and rituximab will be administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6.
Conditions
This trial is treating patients with mantle cell lymphoma
Eligibility
Inclusion
- ≥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
Exclusion
- 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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
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