Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
226
Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle
Eligible patients will receive Orelabrutinib orally as per the protocol,once daily for every 28 days as one treatment cycle
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
Time frame: Up to 6 years
Changes from baseline in pulse.
Time frame: Up to 6 years
Changes from baseline in blood pressure.
Time frame: Up to 6 years
Changes from baseline in ECG QRS interval.
Time frame: Up to 6 years
Changes from baseline in ECG QT interval.
Time frame: Up to 6 years
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