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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: ICP-022; Drug: Chlorambucil; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: April Huang; Phone Number: 010-66609723; Email: April.huang@innocarepharma.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Not yet recruiting
      • The First affiliated hospital of bengbu medical college
      • Contact: Yanli Yang
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Qingshu Zeng
    • Hefei, Anhui, China
      • Not yet recruiting
      • Anhui Provincial Cancer Hospital
      • Contact: Kaiyang Ding
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • The Fifth Medical Center of PLA General Hospital
      • Contact: Hang Su
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Not yet recruiting
      • The First Affiliated Hospital of Congqing Medical University
      • Contact: Qing Xiao
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Army Medical University
      • Contact: Qin Wen
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Bing Xu
  • Gansu
    • Lanzhou, Gansu, China
      • Not yet recruiting
      • Lanzhou university second hospital
      • Contact: Liansheng Zhang
  • Guangdong
    • Dongguan, Guangdong, China, 523058
      • Not yet recruiting
      • Dongguan people's hospital
      • Contact: Yirong Jiang; Phone Number: 13688967985
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First People's Hospital
      • Contact: Qingshun Wang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Cancer Prevention and Treatment Center, Sun Yat-sen University
      • Contact: Zhongjun Xia
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • ShenZhen People's Hospital
      • Contact: Xinyou Zhang
  • Guangxi Zhuang Autonomous Region
    • Guilin, Guangxi Zhuang Autonomous Region, China, 541000
      • Not yet recruiting
      • Affiliated Hospital of Guilin Medical College
      • Contact: Wenyuan Lin; Phone Number: 15878361619
  • Hebei
    • Baoding, Hebei, China
      • Not yet recruiting
      • Affiliated Hospital of Hebei University
      • Contact: Luoming Hua
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Lihong Liu
    • Shijiazhuang, Hebei, China, h
      • Recruiting
      • Hebei Medical University Second Hospital
      • Contact: Jinhai Ren
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China
      • Not yet recruiting
      • Affiliated Tumor Hospital of Harbin Medical University
      • Contact: Qingyuan Zhang
  • Henan
    • Luoyang, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Haiping Yang
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Keshu Zhou
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: Mingzhi Zhang
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Province Hospital
      • Contact: Zunmin Zhu
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Not yet recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Fuling Zhou
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Guohui Cui
    • Yichang, Hubei, China
      • Recruiting
      • Yichang Central People's Hospital
      • Contact: Jingming Guo
    • Yichang, Hubei, China
      • Recruiting
      • Yichang First People's Hospital
      • Contact: Kaibo Gao
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Jing Liu
    • Changsha, Hunan, China, 410000
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Hongling Peng
    • Zhuzhou, Hunan, China, 412007
      • Not yet recruiting
      • Zhuzhou Central Hospital
      • Contact: Guoyu Hu; Phone Number: 13707333899
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Jianyong Li
      • Contact: Wei Xu
    • Suzhou, Jiangsu, China
      • Not yet recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Zhengming Jing
    • Wuxi, Jiangsu, China
      • Not yet recruiting
      • Wuxi People's Hospital
      • Contact: Xin Zhou
    • Xuzhou, Jiangsu, China
      • Not yet recruiting
      • Affiliated Hospital of Xuzhou Medical University
      • Contact: Zhenyu Li
    • Yangzhou, Jiangsu, China
      • Not yet recruiting
      • Subei People's Hospital
      • Contact: Jian Gu
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341004
      • Not yet recruiting
      • The First Affiliated Hospital of Gannan Medical College
      • Contact: Yijian Chen; Phone Number: 13576749402
    • Nanchang, Jiangxi, China
      • Recruiting
      • The first affiliated Hospital of Nanchang University
      • Contact: Fei Li
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Cancer Hospital
      • Contact: Yuerong Shuang
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • ShengJing Hospital Of China Medical University
      • Contact: Wei Yang
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • The first affiliated hospital of China medical university
      • Contact: Yan Li
  • Shandong
    • Binzhou, Shandong, China
      • Recruiting
      • Affiliated Hospital of Binzhou Medical College
      • Contact: Wenzheng Yu
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Xin Wang
    • Jinan, Shandong, China, 250117
      • Not yet recruiting
      • Shandong Cancer Hospita
      • Contact: Zengjun Li; Phone Number: 13642138692
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Not yet recruiting
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Jianqing Mi
  • Shanxi
    • Xi'an, Shanxi, China, 710000
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi´an Jiaotong University
      • Contact: Aili, He
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Xiaobing Huang
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: Ting Niu
    • Yibin, Sichuan, China
      • Recruiting
      • Yibin Second People's Hospital
      • Contact: Shihua Huang
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Cancer Hospital
      • Contact: Yafei Wang
      • Contact: Lihua Qiu
    • Tianjin, Tianjin, China
      • Recruiting
      • General Hospital of Tianjin Medical University
      • Contact: Rong Fu
    • Tianjin, Tianjin, China
      • Recruiting
      • Hospital of Hematology, Chinese Academy of Medical Sciences
      • Contact: Lugui Qiu
      • Contact: Shuhua Yi
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830011
      • Not yet recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Jianhua Qu
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Kunming Medical University
      • Contact: Yun Zeng
  • Zhejiang
    • Dongyang, Zhejiang, China, 322199
      • Not yet recruiting
      • Dongyang People's Hospital
      • Contact: Gongqiang Wu; Phone Number: 13757950788
    • Hangzhou, Zhejiang, China, 310026
      • Not yet recruiting
      • Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine
      • Contact: Jin Zhang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University Medical College
      • Contact: Jie Jin
    • Jinhua, Zhejiang, China, 321000
      • Not yet recruiting
      • Jinhua Central Hospital
      • Contact: Huixian Hu; Phone Number: 13588652288
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • Ningbo First Hospital
      • Contact: Guifang Ouyang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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)
2. 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
3. ECOG physical strength score is 0-2.
4. Expected survival time >6 months.
5. Voluntary written informed consent prior to screening.

Key Exclusion Criteria:

1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
3. Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
4. 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.
5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-022; ICP-022 will be orally administered until disease progression or unacceptable toxicity.	Drug: ICP-022; ICP-022 at a dose of 150mg, QD
Active Comparator: Chlorambucil combined with Rituximab; Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.	Drug: Chlorambucil; 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6; Drug: Rituximab; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 5 years
Objective Response Rate (ORR)	Up to 5 years
Duration Of Response (DOR)	Up to 5 years

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Rituximab; Chlorambucil
• Other Study ID Numbers: ICP-CL-00111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No