AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllBeijing InnoCare Pharma Tech Co., Ltd.
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • ICP-248
  • Orelabrutinib
📍

Where

53 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China

…and 45 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy