Actively Recruiting
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
Led by Dizal Pharmaceuticals · Updated on 2025-12-01
155
Participants Needed
17
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
CONDITIONS
Official 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 18 years of age or older
- ECOG performance status of 0 to 2
- Confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma requiring treatment
- Adequate bone marrow function and organ system health
- Willingness to follow contraceptive guidelines
You will not qualify if you...
- Central nervous system involvement or Richter transformation
- Stem cell transplant, cell therapy, or gene therapy within 90 days
- Use of approved small molecule therapy within 5 half-lives or monoclonal antibodies/antibody-drug conjugates within 28 days
- Major surgery or serious injury within 4 weeks
- Receiving live attenuated or viral vector vaccines within 4 weeks
- Use of vitamin K antagonists or more than two anticoagulants or antiplatelet drugs simultaneously
- Use of proton pump inhibitors or strong CYP3A inhibitors or inducers
- Active infection
- Significant cardiac disorders or abnormalities
- History of thrombotic disease, stroke, or intracranial hemorrhage within 6 months
- Uncontrolled nausea/vomiting, chronic gastrointestinal disease, inability to swallow medication, or prior bowel resection affecting absorption
- Another malignancy within 2 years except treated in-situ carcinoma or non-melanomatous skin cancer
- Women who are breastfeeding
- History of allergy to DZD8586 or similar drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
F
Frank Fang
CONTACT
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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