ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
Condition(s) studied
Investigational drug(s) / intervention(s)
ICP-248: Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle
Orelabrutinib: Eligible patients will receive Orelabrutinib orally as per the protocol,once daily for every 28 days as one treatment cycle
Study summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility
Primary outcome measure(s)
- 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
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | Recruiting |
| Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China) | Hefei | Anhui | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Recruiting |
| Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University | Chongqing | Chongqing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Recruiting |
| Gansu Provincial People's Hospital | Lanzhou | Gansu | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Guangdong General Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
| The Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | Not Yet Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| The Affiliated Hospital of North China University of Science and Technology | Tangshan | Hebei | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| Nanyang City Center Hospital | Nanyang | Henan | Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Recruiting |
| Henan Cancer Hospital | Zhenzhou | Henan | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Yichang Central People's Hospital | Yichang | Hubei | Recruiting |
| The Second Xiangya Hospital, Central South University | Changsha | Hunan | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Recruiting |
| Changzhou First People's Hospital | Changzhou | Jiangsu | Not Yet Recruiting |
| Huai'an First People's Hospital | Huai'an | Jiangsu | Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| Bethune First Hospital of Jilin University | Changchun | Jilin | Recruiting |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | Recruiting |
| Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning | Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Shandong Provincial Hospital | Jinan | Shandong | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| Jining First People's Hospital | Jining | Shandong | Recruiting |
| Linyi City Cancer Hospital | Linyi | Shandong | Recruiting |
| Huashan Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Huashan Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | Not Yet Recruiting |
+ 13 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06378138 on ClinicalTrials.gov ↗ ← All trials in China