Leukemia, Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia
Conditions
Keywords
Refractory Chronic Lymphocytic Leukemia, Leukemia, Lymphoma, Small Lymphocytic Lymphoma
Brief summary
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)
Interventions
DRUGBGB-11417
Administered orally
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria 1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or 2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator. 2. Participants who require treatment based on the iwCLL 2018 criteria 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 4. Life expectancy of \> 6 month Key
Exclusion criteria
1. 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 2. 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 3. A known history of or currently suspected Richter's syndrome 4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion) 5. Prior allogeneic stem cell transplant Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) | Up to 2 Years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) as assessed by the investigator | Up to 2 Years | 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) |
| Duration of response (DoR) as determined by the IRC and the investigator | Up to 5 Years | DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first |
| Progression Free Survival (PFS) as determined by the IRC and the investigator | Up to 5 Years | 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 to Response (TTR) as assessed by investigator and IRC | Up to 2 Years | TTR is defined as the time from treatment initiation to the first documented response. |
| Overall Survival (OS) | Up to 5 Years | defined as time from the start of treatment to the date of death due to any cause |
| Participants Reported Outcome as measured by EQ-5D-5L questionnaires | Up to 5 Years | 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). |
| Participant Reported Outcomes as measured by NFLymSI-18 | Up to 5 Years | 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. |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 5 Years | with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies |
| Number of participants with clinically significant changes from baseline in vital signs | Up to 5 Years | Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature |
| Number of participants with clinically significant changes from baseline in clinical laboratory values | Up to 5 Years | Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis |
| Number of Participants With Clinically Significant Physical Examination Findings | Up to 5 Years | A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems |
Countries
China
Outcome results
None listed