RecruitingPhase 2Phase 3NCT06378138
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
226 participants
Start Date
May 15, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria10
- Age ≥ 18 and ≤ 80 years.
- CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
- 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.
- Adequate hematologic function
- Patients with basically normal coagulation function
- Patients with adequate hepatic, renal, pulmonary and cardiac functions
- Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
- Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).
Exclusion Criteria12
- 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.
- History of allogeneic stem cell transplantation.
- Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
- Presence of active infection that requires intravenous anti-infective therapy.
- Hepatitis B or C virus infection.
- History of immunodeficiency disease or Significant cardiovascular disease
- Central nervous system disorders or Severe bleeding disorder
- Alcohol or drug dependence.
- Mental disorders or poor compliance.
Interventions
DRUGICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
DRUGOrelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle
Locations(53)
View Full Details on ClinicalTrials.gov
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NCT06378138
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