This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Eligible patients will receive ICP-248 orally as per the protocol
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)
Time frame: 3 years
Investigator-assessed ORR
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed duration of response (DOR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed time to initial response (TTR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) .
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Adverse event (AE) assessed according to CTCAE v5.0 criteria
Time frame: 3 years
Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L).
Time frame: 3 years
Area under the plasma concentration versus time curve (AUC)
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Chengdu, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITING...and 19 more locations
Time frame: 3 years
minimal residual disease (MRD) status
Time frame: 3 years
Peak Plasma Concentration (Cmax)
Time frame: 3 years
Time of maximum observed plasma(Tmax)
Time frame: 3 years
Trough concentration(Ctrough)
Time frame: 3 years
Apparent clearance (CL/F)
Time frame: 3 years