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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Orally, 50 mg, once daily until treatment discontinuation criterion is met.
Administered intravenously
Administered orally
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGNational Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
RECRUITINGProgression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: Approximately 36 Months
PFS assessed by investigator
Time frame: Approximately 36 Months
Objective response rate (ORR) by IRC and investigator
Time frame: Approximately 36 Months
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Administered intravenously