RecruitingPhase 2NCT07154264
A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Enrollment
66 participants
Start Date
Sep 22, 2025
Study Type
INTERVENTIONAL
Conditions
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 is the dose expansion phase.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria10
- 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.
Interventions
DRUGDZD8586
DZD8586 will be taken orally once daily on days 1-28 of each cycle.
DRUGVenetoclax
Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07154264
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