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).
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms. In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab). Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment. "Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Administered orally
Administered intravenously
Administered orally
Administered intravenously
Administered orally
St Bernards Medical Center
Jonesboro, Arkansas, United States
RECRUITINGUCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
RECRUITINGPih Health Whittier Hospital
Whittier, California, United States
RECRUITINGRocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Time frame: Approximately 36 Months
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death due to any cause.
Time frame: Approximately 36 Months
Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 iwCLL for participants with prior exposure to ncBTKi.
Time frame: Approximately 36 Months
PFS by the Investigator Assessment
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by the investigator using modified 2018 iwCLL criteria for participants with CLL and Lugano classification for participants with SLL
Time frame: Approximately 36 Months
Overall Response Rate (ORR) by IRC and Investigator Assessment
ORR is defined as the percentage of participants with best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), or partial response (PR) as assessed by the IRC or by the investigator.
Time frame: Approximately 36 Months
Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment
Rate of PR-L or higher is defined as the percentage of participants with a best overall response of CR, CRi, nPR, PR, or PR-L as assessed by the IRC or by the Investigator
Time frame: Approximately 36 Months
Duration of Response (DOR) by IRC and Investigator Assessment
DOR is defined as the time from initial response to disease progression or death, whichever occurs first, as assessed by the IRC or by the investigator.
Time frame: Approximately 36 Months
Time to Next Anti-CLL/SLL Treatment (TTNT)
TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.
Time frame: Approximately 36 Months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time frame: Approximately 36 Months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales(fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in GHS and functional scales indicate better quality of life.
Time frame: Approximately 24 Months
Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales
The symptom burden and physical condition will be measured by QLQ-CLL17. EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning. Each question is rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. Higher scores represent higher levels of symptom burden, physical condition/fatigue, or worries/fears about health and functioning.
Time frame: Approximately 24 Months
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Florida Oncology and Hematology
Fort Myers, Florida, United States
RECRUITINGBaptist Md Anderson Cancer Center
Jacksonville, Florida, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGEmory University Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGOur Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
RECRUITINGAmerican Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
RECRUITING...and 104 more locations