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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

Study acronym: CaDAnCe-303
StatusActive, Not Recruiting
PhasePhase 3
Started2025-05-29
View on ClinicalTrials.gov ↗

Amendment history

2026-08-21
Study Status, Arms and Interventions v17
Re-verified, no change to tracked fields
2026-08-06
Study Status, Contacts/Locations v16
Trial sites reduced: 62 → 56 locations
2026-07-23
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v15
Study sites64→62
InterventionsBGB-16673 (Drug), Bendamustine (Drug), Methylprednisolone (Drug), Rituximab (Drug)→BGB-16673 (Drug), Bendamustine (Drug), Chlorambucil (Drug), Methylprednisolone (Drug), Obinutuzumab (Drug), Rituximab (Drug)
Eligibility criteria+28 characters
[...] and excipients of study treatment (BGB-16673, bendamustine, rituximab, chlorambucil, or rituximabobinutuzumab) Current or history of central nervous system involvement H [...]
Study description+34 characters
[...] lus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab. The main purpose of this study is to compare the length of [...]
2026-06-26
Study Status, Study Design, Contacts/Locations v14
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment target150→153
Study sitesdetails revised at 64 of 64 sites
2026-06-18
Study Status, Contacts/Locations v13
Study sitesdetails revised at 19 of 64 sites
Show 12 earlier versions
2026-05-08
Study Status, Contacts/Locations v12
Study sites64 entries, revised
Sun Yat Sen University Cancer CenterhuangpuCenter Huangpu Branch
2026-04-21
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 64 sites
2026-01-05
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v10
Lead sponsorBeiGene→BeOne Medicines
Study sites64 entries, revised
Sun Yat Sen University Cancer Center(HuangpuCenterhuangpu Campus)Branch ThePeoples Hospital of Xinjiang Uygur Autonomous Region Peoples Hospital
2025-11-20
Study Identification, Study Status, Contacts/Locations v9
Study sitesdetails revised at 5 of 64 sites
2025-09-23
Study Status, Contacts/Locations v8
Study sitesdetails revised at 5 of 64 sites
2025-09-12
Study Status, Contacts/Locations v7
Study sitesdetails revised at 5 of 64 sites
2025-08-19
Study Status, Contacts/Locations v6
Study sitesdetails revised at 7 of 64 sites
2025-08-05
Study Status, Contacts/Locations v5
Study sitesdetails revised at 16 of 64 sites
2025-07-24
Study Status, Contacts/Locations v4
Study sitesdetails revised at 24 of 64 sites
2025-06-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-02→confirmed 2025-05-29
Study sites0→64
2025-05-27
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2025-05-15
Study Identification, Study Status, Study Description, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 10 entries
Study title+25 characters
[...] r Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
2025-05-06
Original filing
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).
Trial Details
NCT Number NCT06970743
Lead Sponsor BeOne Medicines
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 153 participants
Start Date 2025-05-29
Primary Completion 2029-11-30 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-24