DZD8586 plus venetoclax for CLL/SLL

A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

This will try DZD8586 together with venetoclax in adults with newly diagnosed or treatment‑naïve CLL/SLL who need therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (Industry-sponsored)
• Locations: 15 sites (Hefei, Anhui and 14 other locations)
• Trial ID: NCT07154264 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with newly diagnosed or treatment‑naïve CLL/SLL who need therapy, have ECOG performance status 0–2, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with CNS involvement, known or suspected Richter's transformation, active infection, severe cardiac or pulmonary disease, poorly controlled autoimmune cytopenias, recent other cancers, known allergy to the study drugs, or prior prohibited treatments are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could increase remission rates and provide a new treatment option for people with CLL/SLL while keeping side effects manageable.

How similar studies have performed: Venetoclax-based combinations have shown strong activity in CLL, but DZD8586 is a newer agent so this exact combination is novel and not yet proven.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 14 other locations

• 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)
• Yichang Central People's Hospital — Yichang, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Niu — West China Hospital
• Study coordinator: Ling Zhou

Conditions Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma