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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BGB-16673

Administered orally

DRUG

Bendamustine

Administered intravenously

DRUG

Idelalisib

Administered orally

DRUG

Rituximab

Administered intravenously

DRUG

Venetoclax

Administered orally

Locations (20)

St Bernards Medical Center
Jonesboro, Arkansas, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Pih Health Whittier Hospital
Whittier, California, United States
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Florida Oncology and Hematology
Fort Myers, Florida, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
University Hospitals
Cleveland, Ohio, United States
Dayton Physician Network
Dayton, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Texas Oncology Tyler
Tyler, Texas, United States