A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

Sponsor
BeOne Medicines
Study ID
NCT06970743
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-16673 — DRUG
    Administered orally
  • Bendamustine — DRUG
    Administered intravenously
  • Rituximab — DRUG
    Administered intravenously
  • Methylprednisolone — DRUG
    Administered intravenously
  • Chlorambucil — DRUG
    Administered orally
  • Obinutuzumab — DRUG
    Administered intravenously

Study Details

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).

Key Dates

First listed
May 14, 2025
Start date
May 29, 2025
Status verified
Aug 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: BGB-16673 Monotherapy
    Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
  • Active Comparator: Arm B: Investigator's Choice
    Participants will receive investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab for up to six 28-day cycles. Participants with unequivocal disease progression confirmed by Independent Review Committee (IRC) may cross over to receive treatment with BGB-16673 at the Investigator's discretion

Primary Outcome Measure

Progression-Free Survival (PFS) by IRC [ Time Frame: Approximately 23 Months ]

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