Actively Recruiting
A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by Dizal Pharmaceuticals · Updated on 2026-06-02
155
Participants Needed
17
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of DZD8586 in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) whose disease has returned, is not responding to earlier treatments, or who cannot tolerate side effects from previous therapies. This phase 2, open-label study aims to understand how well DZD8586 works as a single treatment, what side effects might occur, and how the drug behaves in the body. Participants receive daily oral doses of DZD8586 at one of three levels: 25 mg, 50 mg, or 75 mg. The study is randomized and designed to compare these dosing groups without blinding. The treatment period and dosing schedules are structured to assess the drug's anti-tumor activity and safety. During the study, participants will be monitored regularly for treatment response, side effects, and drug levels in the body. The main outcome measured is the objective response rate, assessed for up to two years. Safety is also closely tracked for 30 days after the last dose and up to two years. The total participation time varies depending on individual treatment and follow-up needs.
CONDITIONS
Brief Title
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 years or older
- ECOG performance status between 0 and 2
- Confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma requiring treatment
- Adequate bone marrow reserve and organ function
- Willingness to follow contraceptive restrictions
You will not qualify if you...
- Central nervous system involvement or Richter transformation
- Stem cell transplantation, cell therapy, or gene therapy within the past 90 days
- Use of approved small molecule therapy within 5 half-lives or monoclonal antibodies/antibody-drug conjugates within 28 days
- Major surgery or significant injury within 4 weeks
- Receipt of live attenuated or viral vector vaccines within 4 weeks
- Use of vitamin K antagonists or more than two anticoagulants/antiplatelet drugs concurrently
- Use of proton pump inhibitors or strong CYP3A inhibitors/inducers
- Active infection
- Significant cardiac disorders or abnormalities, or history of thrombotic disease, stroke, or intracranial hemorrhage within 6 months
- Uncontrolled nausea/vomiting or chronic gastrointestinal disease affecting drug absorption
- Another malignancy within 2 years, except certain treated in-situ carcinomas or non-melanoma skin cancers
- Women who are breastfeeding
- History of hypersensitivity to DZD8586 or similar drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive daily oral doses of DZD8586 at varying amounts to evaluate efficacy, safety, and tolerability.
Regular visits according to dosing schedule
Duration - 30 days after the last dose, assessed up to 2 years
Participants are monitored for safety and adverse events after the last dose of treatment.
Periodic visits for safety assessments
Trial Site Locations
Total: 17 locations
1
Research Site
Hefei, Anhui, China
Actively Recruiting
2
Research Site
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
3
Research Site
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
4
Research Site
Guangzhou, Guandong, China, 510280
Actively Recruiting
5
Research Site
Guangzhou, Guandong, China, 510515
Actively Recruiting
6
Research Site
Zhengzhou, Henan, China
Actively Recruiting
7
Research Site
Wuhan, Hubei, China
Actively Recruiting
8
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
9
Research Site
Changchun, Jilin, China
Actively Recruiting
10
Research Site
Dalian, Liaoning, China
Not Yet Recruiting
11
Research Site
Shenyang, Liaoning, China
Actively Recruiting
12
Research Site
Jinan, Shandong, China
Actively Recruiting
13
Research Site
Linyi, Shandong, China
Actively Recruiting
14
Research Site
Shanghai, Shanghai Municipality, China
Actively Recruiting
15
Research Site
Taiyuan, Shangxi, China
Actively Recruiting
16
Research Site
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
17
Research Site
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
T
Tianmo Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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