Trial Title:
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT ID:
NCT06378138
Condition:
Hematologic Malignancies
Conditions: Official terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-248
Description:
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28
days as one treatment cycle
Arm group label:
ICP-248 in combination with Orelabrutinib
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for
every 28 days as one treatment cycle
Arm group label:
ICP-248 in combination with Orelabrutinib
Summary:
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with
Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Criteria for 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. Suspected 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Ge
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoqiong Tang
Facility:
Name:
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
Address:
City:
Chongqing
Zip:
400037
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xixi Xiang
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhenshu Xu
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Bing Xu
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510055
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Liang
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lihong Liu
Facility:
Name:
Nanyang City Center Hospital
Address:
City:
Nanyang
Zip:
473005
Country:
China
Status:
Recruiting
Contact:
Last name:
Chao Li
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
463599
Country:
China
Status:
Recruiting
Contact:
Last name:
Zunmin Zhu
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhenzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoxi Zhou
Facility:
Name:
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guohui Cui
Facility:
Name:
The Second Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongling Peng
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fang Zhou
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xu
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Bethune First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130061
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ou Bai
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116023
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiuhua Sun
Facility:
Name:
Shengjing Hospital affiliated to China Medical University
Address:
City:
Shenyang
Zip:
Liaoning
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aijun Liao
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ji Ma
Facility:
Name:
Linyi City Cancer Hospital
Address:
City:
Linyi
Zip:
276002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Meifang Zheng
Facility:
Name:
Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Yuan
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianli Wang
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
610072
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaobing Huang
Facility:
Name:
Yibin Second People's Hospital
Address:
City:
Yibin
Zip:
644002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shihua Huang
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lihua Qiu
Facility:
Name:
The Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Urumqi
Zip:
830000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shujuan Wen
Facility:
Name:
The First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Mingxia Shi
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenjuan Yu
Start date:
May 15, 2024
Completion date:
July 25, 2031
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378138
