This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
ICP-022 at a dose of 150mg, QD
0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Progression Free Survival (PFS)
Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014).
Time frame: Up to 5 years
Objective Response Rate (ORR)
Time frame: Up to 5 years
Duration Of Response (DOR)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGThe Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Congqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGLanzhou University Second Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
NOT_YET_RECRUITINGCancer Prevention and Treatment Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITING...and 46 more locations