Status:
RECRUITING
A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
Lead Sponsor:
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Conditions:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07154264
Start Date
September 22 2025
End Date
January 1 2030
Last Update
December 24 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515