RecruitingPhase 2Phase 3NCT06378138

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

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

226 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Hematologic Malignancies

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — ICP-248 and orelabrutinib (both BTK pathway inhibitors) — as a first-time treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), a slow-growing blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with CLL or SLL according to current criteria - You have not yet received treatment and now meet the criteria to start treatment - You have at least one measurable area of disease - Your general health, organ function, and blood counts meet the required levels **You may NOT be eligible if...** - You have already received treatment for CLL/SLL - You do not yet meet criteria to start treatment - You have poor organ function or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICP-248

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

DRUGOrelabrutinib

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

Locations(53)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong General Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Affiliated Hospital of North China University of Science and Technology

Tangshan, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang City Center Hospital

Nanyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhenzhou, Henan, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Bethune First Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Jining First People's Hospital

Jining, Shandong, China

Linyi City Cancer Hospital

Linyi, Shandong, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Blood Diseases Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The People's Hospital Affiliated to Ningbo University

Ningbo, Zhejiang, China

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