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RecruitingLast updated: 4 April 2023

This phase III trial is trying to understand whether it is safer and more effective to combine chemotherapy and targeted therapy for the treatment of mantle cell lymphoma, or to use targeted therapy alone, in patients who are not eligible for a stem cell transplant and have not received prior treatmentA 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

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.

Cancer

Blood Cancers Blood

Age

People65+

Phase

III

More information

Trial Identifiers

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Commercial 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

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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