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

June 2, 2023 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 5 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Objective Response Rate (ORR)
Time Frame: Up to 5 years
Up to 5 years
Duration Of Response (DOR)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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