About this trial
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility criteria
Qualifiers
Age ≥ 18 and ≤ 80 years.
Having an indication for treatment that meets the criteria for iwCLL 2018
Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
Disqualifiers
Central nervous system involvement.
Concomitant Richter transformation.
Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
Trial design
Treatments tested in this trial
- ICP-248
- Orelabrutinib