DZD8586 plus venetoclax for CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, open-label study gives the experimental agent DZD8586 combined with venetoclax to adults with CLL/SLL who require treatment. The trial has two parts: Part A is a safety lead-in to identify a tolerable regimen, and Part B is a dose-expansion phase to measure response rates and safety in a larger group. Eligible participants are adults (≥18) with newly diagnosed or treatment‑naïve disease, ECOG 0–2, adequate organ function, and measurable disease for SLL. Sites are located in China and the study will monitor adverse events, blood counts, tumor responses, and duration of remission.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui Provincial Cancer Hospital
  Hefei, Anhui, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhujiang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Niu — West China Hospital
• Study coordinator: Ling Zhou
• Email: ling.zhou@dizalpharma.com
• Phone: 0086-21-61095755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

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• DZD8586 compared with doctor’s choice treatments for relapsed/refractory CLL/SLL

  This trial will test whether the oral drug DZD8586 works better than commonly chosen treatments for adults with relapsed or refractory CLL/SLL.

  Recruiting at 2 sites Phase 3 Dizal Pharmaceuticals · Nanjing, Jiangsu and 1 other locations · NCT07139873

• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

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• Zanubrutinib plus sonrotoclax for relapsed or refractory B‑cell non‑Hodgkin lymphoma in underrepresented racial and ethnic groups

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• Using acalabrutinib to treat chronic lymphocytic leukemia and small lymphocytic lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.