This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Administered orally
Administered orally
Administered orally
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
Time frame: 6 years
Investigator-assessed PFS according to Lugano 2014.
Time frame: 6 years
IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014
Time frame: 6 years
Time to next treatment (TTNT)
Time frame: 6 years
Overall Survival (OS)
Time frame: 6 years
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: 6 years
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
...and 14 more locations