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

InnoCare Pharma

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hematologic Malignancies

Treatments: Drug: Orelabrutinib; Drug: ICP-248

Study type: Interventional

Funder types: Industry

Identifiers

NCT06378138

ICP-CL-01203

Details and patient eligibility

About

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Enrollment: 226 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 and ≤ 80 years.
2. 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):
3. Having an indication for treatment that meets the criteria for iwCLL 2018
4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
10. 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 criteria

1. Central nervous system involvement.
2. Concomitant Richter transformation.
3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
5. History of allogeneic stem cell transplantation.
6. 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.
7. Presence of active infection that requires intravenous anti-infective therapy.
8. Hepatitis B or C virus infection.
9. History of immunodeficiency disease or Significant cardiovascular disease
10. Central nervous system disorders or Severe bleeding disorder
11. Alcohol or drug dependence.
12. Mental disorders or poor compliance.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 1 patient group

ICP-248 in combination with Orelabrutinib

Experimental group

Treatment:

Drug: ICP-248

Drug: Orelabrutinib