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Comparing BGB-16673 to standard treatments for chronic lymphocytic leukemia

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Phase 3 Interventional BeOne Medicines · NCT06846671

This study is testing a new treatment called BGB-16673 to see if it works better than standard options for people with chronic lymphocytic leukemia who have already tried other therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionschimeric antigen receptor, rituximab
Locations116 sites (Jonesboro, Arkansas and 115 other locations)
Trial IDNCT06846671 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of BGB-16673 in comparison to standard treatment options for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with both Bruton Tyrosine Kinase inhibitors and B-cell Leukemia/Lymphoma 2 Protein inhibitors. Participants will be randomly assigned to receive either BGB-16673 or an investigator's choice of treatment, which may include combinations of idelalisib, rituximab, bendamustine, or venetoclax. The primary goal is to determine how long patients can live without their disease worsening. Approximately 250 participants will be enrolled globally.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with CLL or SLL who have previously received both BTK and BCL2 inhibitors.

Not a fit: Patients with known prolymphocytic leukemia, Richter's transformation, or significant cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory CLL or SLL.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
5. Adequate liver function
6. Adequate blood clotting function

Exclusion Criteria:

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
3. Known central nervous system involvement
4. Prior exposure to any BTK protein degraders
5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
6. Clinically significant cardiovascular disease

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

Where this trial is running

Jonesboro, Arkansas and 115 other locations

+66 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CLLChronic Lymphocytic Leukemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.