A Study of Tacabrutideg (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
About this study
The purpose of this study is to investigate the efficacy and safety of tacabrutideg 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).
- Condition
- CLL, Chronic Lymphocytic Leukemia
- Tested
- Tacabrutideg, Bendamustine, Idelalisib, Rituximab, Venetoclax
- Sponsor
- BeOne Medicines
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: CLL, Chronic Lymphocytic Leukemia
- 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
Exclusion 7
- 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.
Where
132 sites, 132 recruiting
Hospital Aleman
Caba, Argentina
CEMIC
Caba, Argentina
FUNDALEU
Caba, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina
Cice 9 de Julio Sanatorio 9 de Julio
San Miguel de Tucumán, Argentina
and 126 more sites on ClinicalTrials.gov
Contact
-
Study Director
1.877.828.5568 clinicaltrials@beonemed.com
Potential match only. Final eligibility is determined by the study team.