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RecruitingLast updated: 14 November 2025

A study recruiting people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma to compare the effectiveness of two targeted therapiesA Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This is a phase 3 trial evaluating the efficacy and safety of BGB-16673 targeted therapy when compared with pirtobrutinib targeted therapy in people with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Eligible participants will be randomly allocated into one of 2 treatment arms. One arm will receive BGB-16673 orally while the other arm receives Pirtobrutinib (Jaypirca) orally. 

To be eligible you must not have known prolymphocytic leukaemia or history of, or currently suspected, Richter's transformation.

Conditions

This trial is treating people with relapsed/refractory Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma.

Eligibility

Inclusion

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
  • Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
  • Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

Exclusion

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
  • Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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