Tests DZD8586 in adults with returning or unresponsive chronic lymphocytic leukemia
Tests the drug DZD8586 alone in adults whose leukemia returned or stopped responding.
Plain-language title generated from the registry record
Registry title: DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
Key facts
- Where
- Beijing, Changchun, Dalian, Guangzhou, Hefei, Jinan, Linyi, Nanjing, Shanghai, Shenyang, Taiyuan, Tianjin, Wuhan, and Zhengzhou, ChinaSee the 14 sites
- Phase
- Phase 2
Where in China
- BeijingBeijing, ChinaTaking people
- ChangchunChangchun, ChinaTaking people
- DalianDalian, ChinaNot yet recruiting
- GuangzhouGuangzhou, ChinaTaking people
- HefeiHefei, ChinaTaking people
- JinanJinan, ChinaTaking people
- LinyiLinyi, ChinaTaking people
- First Affiliated Hospital of Nanjing Medical University, Jiangsu Province HospitalNanjing, ChinaTaking people
- ShanghaiShanghai, ChinaTaking people
- ShenyangShenyang, ChinaTaking people
- TaiyuanTaiyuan, ChinaTaking people
- TianjinTianjin, ChinaTaking people
- WuhanWuhan, ChinaTaking people
- ZhengzhouZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dizal Pharmaceuticals
- Trial code
- NCT06539182
- Record updated
- 2 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants who meet all the following criteria:; Male and female ≥ 18 years of age; ECOG performance status 0-2; Confirmed diagnosis of CLL/SLL with indication for treatment; Adequate bone marrow reserve and organ system functions; Willing to comply with contraceptive restrictions.
Exclusion: 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; Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks; 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; Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption; 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; Active infection; Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months; History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class; Participants who meet any of the following criteria:; CNS involvement or Richter transformation; Women who are breast feeding.