NCT04002297 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

65+Age Over 65

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaLymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

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 treatment .
 

This trial is treating patients with mantle cell lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

BeiGene Australia Pty Ltd

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.

Recruiting Hospitals Read MoreRead more

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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