Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
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.
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.
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTLing Zhou
PRINCIPAL_INVESTIGATORNiu
West China Hospital
Outcome results
None listed