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
1 other identifier
interventional
226
1 country
53
Brief Summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Longer than P75 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 25, 2031
November 21, 2025
October 1, 2025
6.5 years
April 6, 2024
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
Up to 6 years
Changes from baseline in pulse.
Up to 6 years
Changes from baseline in blood pressure.
Up to 6 years
Changes from baseline in ECG QRS interval.
Up to 6 years
Changes from baseline in ECG QT interval.
Up to 6 years
Study Arms (1)
ICP-248 in combination with Orelabrutinib
EXPERIMENTALInterventions
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, 400037, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510055, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010, China
The Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Nanyang City Center Hospital
Nanyang, Henan, 473005, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 463599, China
Henan Cancer Hospital
Zhenzhou, Henan, 450003, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430011, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410012, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Changzhou First People's Hospital
Changzhou, Jiangsu, 213003, China
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Bethune First Hospital of Jilin University
Changchun, Jilin, 130061, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Jining First People's Hospital
Jining, Shandong, 272011, China
Linyi City Cancer Hospital
Linyi, Shandong, 276002, China
Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, 201108, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Yibin Second People's Hospital
Yibin, Sichuan, 644002, China
Blood Diseases Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300120, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300181, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The People's Hospital Affiliated to Ningbo University
Ningbo, Zhejiang, 315040, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2024
First Posted
April 22, 2024
Study Start
May 15, 2024
Primary Completion (Estimated)
November 25, 2030
Study Completion (Estimated)
July 25, 2031
Last Updated
November 21, 2025
Record last verified: 2025-10