ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

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

Treatment groups

226 Participants
are divided into 1 treatment group