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Recruiting NCT06378138

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

Phase II / Phase III Interventional Hematologic Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-248, Orelabrutinib.
Who it may be relevant to
Registry conditions: Hematologic Malignancies. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Overview

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

Interventions

  • Drug ICP-248
    Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
  • Drug Orelabrutinib
    Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 53 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Tech — Hefei
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Peking University Third Hospital — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University — Chongqing
  • Fujian Medical University Union Hospital — Fuzhou
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • … and 45 more centers

Identifiers

NCT: NCT06378138 · ICP-CL-01203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗