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A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

RecruitingPhase 2Ages 18 Years - anyAllDizal Pharmaceuticals
NCT07154264 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL. This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male and female ≥ 18 years of age. 2. ECOG performance status 0-2, and life expectancy ≥ 6 months. 3. Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment. 4. Patients with SLL must have at least one measurable lesion. 5. Adequate bone marrow reserve and organ functions. 6. Willing to comply with contraceptive restrictions. Exclusion Criteria: 1. Any of previous or current treatment prohibited by protocol. 2. Any unresolved \> grade 1 drug-related adverse events. 3. Known or suspected Richter's transformation, or prolymphocytic leukemia. 4. CNS involvement. 5. Active infection. 6. Any of severe cardiac or pulmonary abnormalities. 7. Poorly controlled autoimmune anemia or autoimmune thrombocytopenia. 8. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases. 9. Prior malignancy within the past 3 years. 10. Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.
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What it tests

  • DZD8586
  • Venetoclax
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Where

15 sites
Anhui Provincial Cancer Hospital
Hefei, China
Peking University Third Hospital
Beijing, China
Zhujiang Hospital of Southern Medical University
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Henan Cancer Hospital
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Yichang Central People's Hospital
Yichang, China
Hunan Cancer Hospital
Changsha, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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