Clinical trial NCT06378138: ICP-248 in Combination with Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title: A Phase II/III Study of ICP-248 in Combination with Orelabrutinib in Patients with Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hematologic Malignancies
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
timeFrame: Up to 6 years
measure: Changes from baseline in pulse.
timeFrame: Up to 6 years
measure: Changes from baseline in blood pressure.
timeFrame: Up to 6 years
measure: Changes from baseline in ECG QRS interval.
timeFrame: Up to 6 years
measure: Changes from baseline in ECG QT interval.
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: The Affiliated Hospital of North China University of Science and Technology
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang City Center Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhenzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi City Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Blood Diseases Hospital of Chinese Academy of Medical Sciences
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang Uygur Autonomous Region
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The People's Hospital Affiliated to Ningbo University
state: Zhejiang
Study officials:
References: