BGB-3111-302 : A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects with Waldenstrom's Macroglobulinemia (WM)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma

Trial Overview Read MoreRead more

This phase III trial is comparing two drugs (BGB-3111 and ibrutinib) in the treatment of Waldenström's Macroglobulinemia (a type of Non Hodgkin Lymphoma).
 

This trial is treating patients with Waldenström’s Macroglobulinemia.

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 been diagnosed with a prior or secondary type of cancer.
  • 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 the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects with Waldenstrom's Macroglobulinemia (WM)

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenstrom's Macroglobulinemia. This open-label, randomized study will compare the efficacy and safety of the Bruton's Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in subjects with Waldenström's Macroglobulinemia who require therapy. Subjects will have baseline bone marrow samples assayed for sequencing of the MYD88 gene. Approximately 150 subjects with the MYD88 mutation will be enrolled onto Cohort 1 and randomized to receive 160 mg BGB-3111 PO BID (treatment Arm A) or to receive 420mg ibrutinib QD (treatment Arm B) until disease progression or unacceptable toxicity. Subjects with MYD88 wild type will be enrolled to Cohort 2 and will receive 160 mg BGB-3111 PO BID (treatment Arm C) until disease progression or unacceptable toxicity.

Recruiting Hospitals Read MoreRead more

Frankston Hospital
Frankston
Ms Judy Reilly
judithreilly@phcn.vic.gov.au
03 9784 8520

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

Not Recruiting Hospitals Read MoreRead more

Closed

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

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

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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