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Closed (no longer recruiting)Last updated: 9 January 2024

BGB-3111-304 (TN CLL): 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)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)

Clinical 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.


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


Blood Cancers Haematological





Trial Acronym

BGB-3111-304 (TN CLL)

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Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

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)



  • Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
  • Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
  • Measurable disease by imaging
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Life expectancy ≥ 6 months
  • Adequate bone marrow function
  • Adequate renal and hepatic function


  • Previous systemic treatment for CLL/SLL
  • Requires ongoing need for corticosteroid treatment
  • Known prolymphocytic leukemia or history of or suspected Richter's transformation.
  • Clinically significant cardiovascular disease
  • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer
  • History of severe bleeding disorder
  • History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
  • Severe or debilitating pulmonary disease
  • Inability to swallow capsules or disease affecting gastrointestinal function
  • Active infection requiring systemic treatment
  • Known central nervous system involvement by leukemia or lymphoma
  • Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs
  • Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection
  • Major surgery ≤ 4 weeks prior to start of study treatment
  • Pregnant or nursing females
  • Vaccination with live vaccine within 35 days prior to the first dose of study drug.
  • Ongoing alcohol or drug addiction
  • Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs
  • Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer
  • Concurrent participation in another therapeutic clinical study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


  • You have been diagnosed with cancer, but have not received any treatment.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • 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.

Ask your doctor if this trial could be right for you.

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