Comparing BGB-16673 to standard treatments for chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St Bernards Medical Center
  Jonesboro, Arkansas, United States Recruiting
• UCLA Department of Medicine Hematologyoncology
  Los Angeles, California, United States Recruiting
• Scripps Prebys Cancer Center
  San Diego, California, United States Recruiting
• Pih Health Whittier Hospital
  Whittier, California, United States Recruiting
• Rocky Mountain Cancer Centers (Williams) Usor
  Aurora, Colorado, United States Recruiting
• Intermountain Health Lutheran Hospital Cancer Center of Colorado
  Golden, Colorado, United States Recruiting

+82 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.