DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
NCT ID: NCT06539182
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
155 participants
INTERVENTIONAL
2024-04-29
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Daily dose of DZD8586 at 25 mg
DZD8586
Daily oral dose of DZD8586 at 25 mg.
Daily dose of DZD8586 at 50 mg
DZD8586
Daily oral dose of DZD8586 at 50 mg.
Daily dose of DZD8586 at 75 mg
DZD8586
Daily oral dose of DZD8586 at 75 mg.
Interventions
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DZD8586
Daily oral dose of DZD8586 at 25 mg.
DZD8586
Daily oral dose of DZD8586 at 50 mg.
DZD8586
Daily oral dose of DZD8586 at 75 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of CLL/SLL with indication for treatment.
4. Adequate bone marrow reserve and organ system functions.
5. Willing to comply with contraceptive restrictions.
Exclusion Criteria
1. CNS involvement or Richter transformation.
2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
5. Active infection.
6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
18 Years
ALL
No
Sponsors
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Dizal Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jianyong Li
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Locations
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Research Site
Hefei, Anhui, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guandong, China
Research Site
Guangzhou, Guandong, China
Research Site
Zhengzhou, Henan, China
Research Site
Wuhan, Hubei, China
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Dalian, Liaoning, China
Research Site
Shenyang, Liaoning, China
Research Site
Jinan, Shandong, China
Research Site
Linyi, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Taiyuan, Shangxi, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Other Identifiers
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DZ2023B0002
Identifier Type: -
Identifier Source: org_study_id
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