NCT07139873

A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy. Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.

Conditions

• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	DZD8586	Orally, 50 mg, once daily until treatment discontinuation criterion is met.
DRUG	Bendamustine	Administered intravenously
DRUG	Idelalisib	Administered orally
DRUG	Rituximab	Administered intravenously

Timeline

• Start date: 2025-09-08
• Primary completion: 2029-01-01
• Completion: 2029-12-01
• First posted: 2025-08-24
• Last updated: 2026-03-27

Locations

2 sites across 1 country: China