A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)
Not Applicable
Not yet recruiting
- Conditions
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT07154264
- Lead Sponsor
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- 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 is the dose expansion phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination of DZD8586 and Venetoclax DZD8586 DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1. Combination of DZD8586 and Venetoclax Venetoclax DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
- Primary Outcome Measures
Name Time Method Part A: Incidence of Adverse Events 30 days after the last dose Part B: 2-year progression free survival (PFS) rate assessed by investigator Approximately 5 years
- Secondary Outcome Measures
Name Time Method Part A: PFS assessed by investigator Approximately 5 years Part A: Objective response rate (ORR) assessed by investigator Approximately 5 years Part B: ORR assessed by investigator Approximately 5 years Part B: Incidence of Adverse Events 30 days after the last dose