Actively Recruiting
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Led by Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Updated on 2026-03-27
250
Participants Needed
2
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 years of age or older
- ECOG performance status between 0 and 2
- Confirmed diagnosis of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma requiring treatment
- Adequate bone marrow reserve and organ function
- Willingness to comply with contraceptive restrictions
You will not qualify if you...
- Presence of any unresolved adverse event of greater than Grade 1 at the start of study treatment
- Known or suspected Richter transformation
- Known or suspected central nervous system involvement
- Prior or current therapies or medications that meet exclusion criteria
- Major cardiovascular disease, active infection, malignancy, or uncontrolled systemic disease
- Uncontrolled nausea, vomiting, chronic gastrointestinal disease, inability to swallow the study drug, or previous bowel surgery affecting absorption
- Women who are breastfeeding
- History of allergy to DZD8586 or similar drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
2
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
F
Frank Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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