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

BGB-3111-305: This Phase III trial will be comparing two oral therapies (Zanubrutinib versus Ibrutinib) in patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma that has got worse or not responded to prior treatmentA Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Clinical summary

Summary

Patients in this trial will be randomised 1:1 to receive an oral 160mg dose of Zanubrutinib twice daily or an oral 420mg dose of Ibrutinib once daily. The primary endpoint for the trial will be overall response rate as determined by independent central review.

Conditions

This trial is treating patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

BGB-3111-305

More information

Trial Identifiers

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

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Eligibility

Inclusion

  1. Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
  2. CLL/SLL requiring treatment per 2008 IWCLL criteria
  3. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  4. Measurable disease by Computerized Tomography (CT)/magnetic resonance imaging (MRI)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  6. Life expectancy ≥ 6 months
  7. Adequate bone marrow function
  8. Adequate renal and hepatic function

Exclusion

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. Clinically significant cardiovascular disease.
  3. 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 or breast
  4. History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by leukemia or lymphoma
  9. Known infection with HIV or active viral hepatitis B or C infection
  10. Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
  11. Major surgery within 4 weeks of the first dose of study drug
  12. Prior treatment with a (Burton's Kinase) BTK inhibitor
  13. Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
  14. Pregnant or lactating women
  15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
  16. Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
  17. Concurrent participation in another therapeutic clinical trial

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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

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