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Compares treatment options for CLL
Official title A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
ClinicalTrials.gov ID: NCT06846671
What this study is testing
What is BGB-16673?
BGB-16673 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Adequate liver function
You likely can't join if
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- Known central nervous system involvement
- Prior exposure to any BTK protein degraders
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full eligibility criteria
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Adequate liver function
- Adequate blood clotting function
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- Known central nervous system involvement
- Prior exposure to any BTK protein degraders
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Los Angeles, California, United States
- Whittier, California, United States
- Aurora, Colorado, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Baton Rouge, Louisiana, United States
- Bethesda, Maryland, United States
- Springfield, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Westbury, New York, United States
- Cleveland, Ohio, United States
- Dayton, Ohio, United States
- Eugene, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- York, Pennsylvania, United States
- Tyler, Texas, United States
+ 93 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Los Angeles, California, United States; Whittier, California, United States; Aurora, Colorado, United States; Fort Myers, Florida, United States; Jacksonville, Florida, United States and 107 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.