臨床研究等提出・公開システム

Date of registration	Dec. 24, 2025
Last modified on	Dec. 24, 2025
Trial ID	jRCT2031250598

Scientific Title	A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Public Title	CaDance304

Contact for Scientific Queries	Name	Asano Shinichiro
	Affiliation	BeOne Medicines Japan
	Address	Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan
	Telephone	+81-800-919-0351
	E-mail	MedInfoJP@beigene.com
Contact for Public Queries	Name	Hamano Fumiaki
	Affiliation	BeOne Medicines Japan
	Address	Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan
	Telephone	+81-800-919-0351
	E-mail	MedInfoJP@beigene.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 31, 2026
Target sample size		500
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		B-cell malignancies
Intervention(s)		Arm A: BGB-16673 Participants will receive BGB-16673 orally Arm B: Pirtobrutinib Participants will receive pirtobrutinib orally.
Health Condition(s) Keyword		BTK,CLL,SLL
Health Condition(s) Code		D016393
Primary Outcome(s)		Progression-Free Survival (PFS) per Independent Review Committee (IRC)
Secondary Outcome(s)		Overall Survival (OS),PFS per Investigator (INV),Duration of Response (DOR) per IRC and INV

Primary Sponsor	BeOne Medicines

Name of Certified Review Board	The Cancer Institute Hospital Of JFCR, IRB
Address	3-8-31, Ariake, Koto, Tokyo ,Japan, Tokyo
Telephone	+81-3-3520-0111
Approval Status	Approval
Date of approval	Sept. 25, 2025

Plan to share IPD	No

Secondary ID(s)	NCT06973187

Countries of Recruitment（Except Japan）	Australia/New Zealand/Singapore/United States