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

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT07154264

Run by

Dizal Pharmaceuticals

People needed

66

Starts

2025-09-22

Expected to finish

2030-01-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female ≥ 18 years of age.
• ECOG performance status 0-2, and life expectancy ≥ 6 months.
• Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
• Patients with SLL must have at least one measurable lesion.
• Adequate bone marrow reserve and organ functions.
• Willing to comply with contraceptive restrictions.

You may not qualify if…

• Any of previous or current treatment prohibited by protocol.
• Any unresolved > grade 1 drug-related adverse events.
• Known or suspected Richter's transformation, or prolymphocytic leukemia.
• CNS involvement.
• Active infection.
• Any of severe cardiac or pulmonary abnormalities.
• Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
• Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
• Prior malignancy within the past 3 years.
• Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.

Where it is running

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Yichang Central People's Hospital — Yichang, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (enrolling)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China

Full record on ClinicalTrials.gov

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