Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Overview
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Brief Summary
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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)

Official Title
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A A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Conditions
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Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma, Leukemia, Relapsed Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: BGB-11417


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator. Participants who require treatment based on the iwCLL 2018 criteria Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Life expectancy of > 6 month Key Exclusion Criteria Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results A known history of or currently suspected Richter's syndrome Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion) Prior allogeneic stem cell transplant Note: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol | Drug: BGB-11417<br>* Administered orally<br>* Other names: sonrotoclax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 patients with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for patients with small lymphocytic lymphoma (SLL) | Up to 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 patients with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for patients with small lymphocytic lymphoma (SLL) | 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 | 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. | 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. | Up to 2 Years | 
| Overall Survival (OS) | defined as time from the start of treatment to the date of death due to any cause | 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). | 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 (FLymSI-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. | 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 | 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 | 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 | 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 | Up to 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Leukemia, Lymphoma