B-cell malignancies BTK,CLL,SLL
Conditions
Interventions
Arm A: BGB-16673
Participants will receive BGB-16673 orally
Arm B: Pirtobrutinib
Participants will receive pirtobrutinib orally.
Sponsors
Asano Shinichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria 2.Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi. 3.Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as >= 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Exclusion criteria
Exclusion criteria: 1.Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation. 2.History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 3.History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug 4.Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi). 5.Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) per Independent Review Committee (IRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS),PFS per Investigator (INV),Duration of Response (DOR) per IRC and INV | — |
Countries
Australia, Japan, New Zealand, Singapore, United States
Contacts
Public ContactFumiaki Hamano
BeOne Medicines Japan
Outcome results
None listed