A Phase 3, Open-Label, Randomized Study of BGB-16673
Research type
Research Study
Full title
A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator’s Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
IRAS ID
1011449
Contact name
Mandeep Kalia
Contact email
Sponsor organisation
BeiGene, Ltd.
Eudract number
2024-518893-15
Research summary
Chronic Lymphocytic Leukaemia (CLL) is the most prevalent adult leukaemia in Western countries. Therapies including BTKi and BCL2i have improved patient outcomes, however, survival rates in patients whose CLL relapses after BTKi and BCL2i are poor and subsequent treatment options are limited, representing a significant unmet need. Small Lymphocytic Lymphoma (SLL) is considered to be a different clinical manifestation of the same disease. BGB-16673 is a potent, selective and orally available BTK-targeted protein degrader. Preliminary clinical data demonstrated an acceptable safety profile and promising efficacy in various B-cell malignancies including CLL/SLL. This multicenter, Phase 3, open-label, randomized study will evaluate the efficacy and safety of BGB-16673 alone Arm A, compared with investigator’s choice, Arm B (idelalisib plus rituximab [CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment). Study duration is approx 58 months, excluding screening. 250 patients will be enrolled and randomly assigned in a 3:2 ratio to receive either Arm A or Arm B and will receive treatment until completion of the fixed-duration therapy (Arm B) or any treatment discontinuation criteria is met. Patients in Arm B will be given the option to crossover to Arm A after confirmation of progressive disease. Disease response will be evaluated using modified 2018 iwCLL guidelines with modification for treatment-related lymphocytosis for CLL and Lugano classification for SLL. Patients enrolled will be at least 18 years of age with a confirmed diagnosis of CLL or SLL. Patients must have previously received treatment for CLL or SLL with both a BTKi and a BCL2i. Patients must also have measurable disease (for SLL only), no history of prolymphocytic leukemia or Richter’s transformation at time of consideration; adequate organ/bone marrow function, no ongoing cardiovascular disease; and no active infection including hepatitis B or C virus or HIV.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0083
Date of REC Opinion
25 Apr 2025
REC opinion
Further Information Favourable Opinion