The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).
Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL 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 R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. 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. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered orally
Administered intravenously
Administered intravenously
Administered intravenously
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Peoples Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
Progression-Free Survival (PFS) 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 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with R/R CLL and the Lugano Classification for patients with R/R SLL.
Time frame: Approximately 23 Months
PFS as Assessed by the Investigator
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 the Lugano Classification for patients with R/R SLL.
Time frame: Approximately 12 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 21 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 23 Months
Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by Investigator Assessment
Rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), partial response (PR), or partial response with lymphocytosis (PR-L) as assessed by the Investigator.
Time frame: Approximately 23 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 9 Months
Time to Response (TTR) by IRC and Investigator Assessment
TTR is defined as the time from randomization until initial response, as assessed by the IRC or by the investigator.
Time frame: Approximately 6 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 14 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) and laboratory abnormalities graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Time frame: Approximately 14 Months
Change from baseline in European Organization of Research and Treatment of Cancer (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: Baseline and up to approximately 23 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 (GHS)/Quality of Life (QoL) 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). The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. Higher scores in GHS and functional scales indicate better quality of life.
Time frame: Baseline and up to approximately 23 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGSun Yat Sen University Cancer Center Huangpu Branch
Guangzhou, Guangdong, China
RECRUITING...and 54 more locations