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Taking people in ChinaPhase 2/3

Tests ICP-248 with orelabrutinib in untreated chronic lymphocytic leukemia

Tests ICP-248 and orelabrutinib together in adults newly diagnosed with chronic lymphocytic leukemia.

Plain-language title generated from the registry record
Registry title: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Key facts

Where
Beijing, Bengbu, Changchun, Changsha, Changzhou, Chengdu, Chongqing, Dalian, Fuzhou, Guangzhou, Hangzhou, Hefei, Huai'an, Jinan, Jining, Kunming, Lanzhou, Linyi, Luoyang, Nanchang, Nanjing, Nanning, Nanyang, Ningbo, Shanghai, Shenyang, Shijiazhuang, Taiyuan, Tangshan, Tianjin, Ürümqi, Wuhan, Xi'an, Xiamen, Yibin, Yichang, Zhengzhou, Zhenzhou, and Zunyi, ChinaSee the 53 sites
Phase
Phase 2/3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06378138, who can take part

Where in China

  • Peking University Third HospitalBeijing, ChinaTaking people
  • The First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaTaking people
  • Bethune first hospital of jilin universityChangchun, ChinaTaking people
  • Hunan Cancer HospitalChangsha, ChinaTaking people
  • The Second Xiangya Hospital, Central South UniversityChangsha, ChinaTaking people
  • Changzhou First People's HospitalChangzhou, ChinaNot yet recruiting
  • Sichuan Provincial People's HospitalChengdu, ChinaTaking people
  • West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical UniversityChongqing, ChinaTaking people
  • The Second Hospital of Dalian Medical UniversityDalian, ChinaTaking people
  • Fujian Medical University Union HospitalFuzhou, ChinaTaking people
  • Guangdong General HospitalGuangzhou, ChinaNot yet recruiting
  • Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
  • The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
  • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)Hefei, ChinaTaking people
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
  • Huai'an First People's HospitalHuai'an, ChinaTaking people
  • Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
  • Shandong Cancer HospitalJinan, ChinaTaking people
  • Shandong Provincial HospitalJinan, ChinaTaking people
  • Jining First People's HospitalJining, ChinaTaking people
  • The First Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
  • Gansu Provincial People's HospitalLanzhou, ChinaTaking people
  • Linyi City Cancer HospitalLinyi, ChinaTaking people
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • Jiangsu Province HospitalNanjing, ChinaTaking people
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaNot yet recruiting
  • Nanyang City Center HospitalNanyang, ChinaTaking people
  • The People's Hospital Affiliated to Ningbo UniversityNingbo, ChinaTaking people
  • Huashan HospitalShanghai, ChinaTaking people
  • Shanghai Huashan HospitalShanghai, ChinaNot yet recruiting
  • Shengjing Hospital affiliated to China Medical UniversityShenyang, ChinaTaking people
  • The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
  • Shanxi Cancer hospitalTaiyuan, ChinaNot yet recruiting
  • The Second Hospital of Shanxi Medical UniversityTaiyuan, ChinaNot yet recruiting
  • The Affiliated Hospital of North China University of Science and TechnologyTangshan, ChinaTaking people
  • Blood Diseases Hospital of Chinese Academy of Medical SciencesTianjin, ChinaTaking people
  • Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaTaking people
  • Tianjin People's HospitalTianjin, ChinaNot yet recruiting
  • The Affiliated Cancer Hospital of Xinjiang Medical UniversityÜrümqi, ChinaTaking people
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
  • Shaanxi provincial people's hospitalXi'an, ChinaTaking people
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
  • Yibin Second People's HospitalYibin, ChinaTaking people
  • Yichang Central People's HospitalYichang, ChinaTaking people
  • Henan Provincial People's HospitalZhengzhou, ChinaTaking people
  • Henan Cancer HospitalZhenzhou, ChinaTaking people
  • The Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Beijing InnoCare Pharma Tech Co., Ltd.
Trial code
NCT06378138
Record updated
21 November 2025
Original description
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaRead full original descriptionShow less

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

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

Inclusion: 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: Concomitant Richter transformation; Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days; 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; Alcohol or drug dependence; History of allogeneic stem cell transplantation; 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; Mental disorders or poor compliance; Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis; Central nervous system involvement.

ClinicalTrials.gov NCT06378138