BGB-3111-304 (TN CLL) : An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

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 / LymphomaChronic Lymphocytic Leukaemia,Lymphoma

Trial Overview Read MoreRead more

This phase III trial is comparing an oral drug (BGB-3111) with a combined treatment of Bendamustine and Rituximab, in patients with previously untreated Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL).
 

This trial is treating patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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

An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This is a global phase 3, open label, randomized study of BGB-3111 versus bendamustine plus rituximab (B+R) in subjects with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). It includes subjects without del(17p) [Cohort 1] and subjects with del(17p) [Cohort 2]. Subjects in Cohort 1 are randomized 1:1 to BGB-3111, 80mg twice daily (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Subjects in Cohort 2 receive treatment with BGB-3111.

Recruiting Hospitals Read MoreRead more

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

Peninsula Private Hospital
Frankston
Jodie Wainwright
WainwrightJ@ramsayhealth.com.au
03 9788 3647

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

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

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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