What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

December 8, 2025BloodOpen Access

CaDAnCe-304, a phase 3, open-label, randomized study to evaluate the safety and efficacy of Bruton tyrosine kinase degrader BGB-16673 compared with pirtobrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

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Phase 3 trial assesses BGB-16673's safety and progression-free survival in relapsed CLL/SLL, suggesting potential benefits over pirtobrutinib.

To evaluate the safety and efficacy of BGB-16673 compared with pirtobrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Phase 3, open-label, randomized study design
Approximately 500 adults with R/R CLL/SLL enrolled
Randomized 1:1 to receive BGB-16673 or pirtobrutinib
Primary endpoint is progression-free survival assessed by independent review committee
Secondary endpoints include overall survival, patient-reported outcomes, and safety based on NCI CTCAE v5.0.
BGB-16673 shows a promising safety profile and potential for tumor regression
Improved progression-free survival compared to pirtobrutinib is the primary outcome
Assessment of treatment response includes response rate and patient-reported outcomes.

Tam et al. (2025) studied this question.

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Phase 3 trial assesses BGB-16673's safety and progression-free survival in relapsed CLL/SLL, suggesting potential benefits over pirtobrutinib.