The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administered orally
Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)
Time frame: Up to 2 Years
Overall Response Rate (ORR) as assessed by the investigator
Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL)
Time frame: Up to 2 Years
Duration of response (DoR) as determined by the IRC and the investigator
DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first
Time frame: Up to 5 Years
Progression Free Survival (PFS) as determined by the IRC and the investigator
PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 5 Years
Time to Response (TTR) as assessed by investigator and IRC
TTR is defined as the time from treatment initiation to the first documented response.
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Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University Donghai Campus
Quanzhou, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
...and 40 more locations
Time frame: Up to 2 Years
Overall Survival (OS)
defined as time from the start of treatment to the date of death due to any cause
Time frame: Up to 5 Years
Participants Reported Outcome as measured by EQ-5D-5L questionnaires
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to).
Time frame: Up to 5 Years
Participant Reported Outcomes as measured by NFLymSI-18
The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
Time frame: Up to 5 Years
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies
Time frame: Up to 5 Years
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature
Time frame: Up to 5 Years
Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time frame: Up to 5 Years
Number of Participants With Clinically Significant Physical Examination Findings
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Time frame: Up to 5 Years