Status:
RECRUITING
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Lead Sponsor:
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Conditions:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 lymphocy...
Eligibility Criteria
Inclusion
- Male and female participants ≥ 18 years of age.
- ECOG performance status 0-2.
- Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
- Adequate bone marrow reserve and organ system functions.
- Participants willing to comply with contraceptive restrictions.
Exclusion
- Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
- Known or suspected Richter transformation.
- Known or suspected CNS involvement.
- Previous or current therapy and comedications meet exclusion criteria.
- Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07139873
Start Date
September 8 2025
End Date
December 1 2029
Last Update
November 18 2025
Active Locations (2)
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1
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
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