ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL

Last updated: June 2, 2023
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphoma

Treatment

Chlorambucil

Rituximab

ICP-022

Clinical Study ID

NCT04578613
ICP-CL-00111
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Male or female, age ≥65 years old or age >18 years old or <65 years old, age >18 yearsold 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 hadmeasurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm andhad 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.

Exclusion

Key Exclusion Criteria:

  1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomlyassigned.
  2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any othercomponent of the applicable study drug.
  3. Any mental or cognitive impairment that may limit their understanding of the informedconsent, their implementation and their compliance with the study.
  4. Pregnant and lactating women, or subjects of childbearing age who do not want to usecontraception within 180 days from the end of the study period to the end of the studyperiod.
  5. Conditions in which a potentially life-threatening illness or severe organ dysfunctionis not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 218
Treatment Group(s): 3
Primary Treatment: Chlorambucil
Phase: 3
Study Start date:
January 08, 2021
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The First Affiliated Hospital of Congqing Medical University

    Chongqing, Chongqing 400000
    China

    Site Not Available

  • The Second Affiliated Hospital of Army Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Union Hospital affiliated to Fujian Medical University

    Fuzhou, Fujian
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian
    China

    Active - Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong 523058
    China

    Site Not Available

  • Cancer Prevention and Treatment Center, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guilin Medical College

    Guilin, Guangxi Zhuang Autonomous Region 541000
    China

    Site Not Available

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei
    China

    Site Not Available

  • Hebei Medical University Second Hospital

    Shijiazhuang, Hebei h
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Affiliated Tumor Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang
    China

    Site Not Available

  • The first Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Henan Province Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Zhongnan Hospital of WuHan University

    Wuhan, Hubei 430071
    China

    Site Not Available

  • Yichang Central People's Hospital

    Yichang, Hubei
    China

    Active - Recruiting

  • Yichang First People's Hospital

    Yichang, Hubei
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412007
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu
    China

    Site Not Available

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Subei People's Hospital

    Yangzhou, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi 341004
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Dalian, Liaoning
    China

    Active - Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Affiliated Hospital of Binzhou Medical College

    Binzhou, Shandong
    China

    Active - Recruiting

  • Shandong Cancer Hospita

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi´an Jiaotong University

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Yibin Second People's Hospital

    Yibin, Sichuan
    China

    Active - Recruiting

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region 830011
    China

    Site Not Available

  • The first Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

  • Dongyang People's Hospital

    Dongyang, Zhejiang 322199
    China

    Site Not Available

  • Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310026
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Jinhua Central Hospital

    Jinhua, Zhejiang 321000
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

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