It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Affiliated Tumor Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Overall response rate(ORR)
The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
Time frame: Up to 3 years
Occurrence of adverse events and serious adverse events
The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
Time frame: Up to 3 years
Progression free survival(PFS)
The efficacy measured by progression free survival(PFS)
Time frame: Up to 3 years
Duration of response(DOR)
Time frame: Up to 3 years
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The Fourth Hospital of Hebei Medical University
Hebei, Shijiazhuang, China
Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China