Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
About the study
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)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria
1. 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
EXCLUSION CRITERIA
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Leukemia,Lymphoma,Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,Small Lymphocytic Lymphoma,Relapsed Chronic Lymphocytic Leukemia
Age
18+
Phase
PHASE2
Participants Needed
97
Est. Completion Date
Aug 25, 2027
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT05479994
Study Number
BGB-11417-202
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