Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Brief summary
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy. Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.
Interventions
DRUGDZD8586
Orally, 50 mg, once daily until treatment discontinuation criterion is met.
DRUGBendamustine
Administered intravenously
DRUGIdelalisib
Administered orally
DRUGRituximab
Administered intravenously
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants ≥ 18 years of age. 2. ECOG performance status 0-2. 3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment. 4. Adequate bone marrow reserve and organ system functions. 5. Participants willing to comply with contraceptive restrictions.
Exclusion criteria
1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment. 2. Known or suspected Richter transformation. 3. Known or suspected CNS involvement. 4. Previous or current therapy and comedications meet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) assessed by Independent Review Committee (IRC) | Approximately 36 Months |
Secondary
| Measure | Time frame |
|---|---|
| PFS assessed by investigator | Approximately 36 Months |
| Objective response rate (ORR) by IRC and investigator | Approximately 36 Months |
Countries
China
Contacts
CONTACTCong Wei
STUDY_DIRECTORStudy Director
Dizal Pharmaceutical Co., Ltd.
Outcome results
None listed