ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
A Randomized, Controlled, Open, Multicenter Phase 3 Study to Evaluate ICP-022 Versus Chlorambucil Combined With Rituximab for Primary Treatment of Chronic Lymphocytic Leukemia(CLL)/ Small Lymphocytic Lymphoma(SLL)
1 other identifier
interventional
218
1 country
56
Brief Summary
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2021
Typical duration for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 5, 2023
May 1, 2023
4 years
October 1, 2020
June 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014).
Up to 5 years
Secondary Outcomes (3)
Objective Response Rate (ORR)
Up to 5 years
Duration Of Response (DOR)
Up to 5 years
Overall Survival (OS)
Up to 5 years
Study Arms (2)
ICP-022
EXPERIMENTALICP-022 will be orally administered until disease progression or unacceptable toxicity.
Chlorambucil combined with Rituximab
ACTIVE COMPARATORChlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
Interventions
0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Eligibility Criteria
You may qualify if:
- Male or female, age ≥65 years old or age \>18 years old or \<65 years old, age \>18 years old or \<65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) \> 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment)
- Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
- ECOG physical strength score is 0-2.
- Expected survival time \>6 months.
- Voluntary written informed consent prior to screening.
You may not qualify if:
- Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
- Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
- Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
- Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period.
- Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Congqing Medical University
Chongqing, Chongqing Municipality, 400000, China
The Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, 523058, China
Cancer Prevention and Treatment Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541000, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Hebei Medical University Second Hospital
Shijiazhuang, Hebei, h, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Province Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of WuHan University
Wuhan, Hubei, 430071, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Yichang First People's Hospital
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Subei People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 341004, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Shandong Cancer Hospita
Jinan, Shandong, 250117, China
Shandong Provincial Hospital
Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The Second Affiliated Hospital of Xi´an Jiaotong University
Xi’an, Shanxi, 710000, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830011, China
The first Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Dongyang People's Hospital
Dongyang, Zhejiang, 322199, China
Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310026, China
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, 321000, China
Ningbo First Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
January 8, 2021
Primary Completion
December 30, 2024
Study Completion
June 30, 2025
Last Updated
June 5, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share