AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3NCT04578613

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

A Phase 3 study testing ICP-022, Chlorambucil and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 56 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ICP-022, Chlorambucil and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
56 sitesChina
Study dates
8 Jan 2021to 30 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

56 sites in 1 country.

April Huang contact

010-66609723

April.huang@innocarepharma.com

56 sites in 1 country

China56 sites, 56 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

    Luoming Hua

    Not yet recruiting

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality

    Hang Su

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Yanli Yang

    Not yet recruiting

  • Affiliated Hospital of Binzhou Medical College

    Binzhou, Shandong

    Wenzheng Yu

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Hongling Peng

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Jing Liu

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Xiaobing Huang

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Ting Niu

    Not yet recruiting

  • The First Affiliated Hospital of Congqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Qing Xiao

    Not yet recruiting

  • The Second Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality

    Qin Wen

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Dalian, Liaoning

    Wei Yang

    Recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523058

    Yirong Jiang, 13688967985

    Not yet recruiting

  • Dongyang People's Hospital

    Dongyang, Zhejiang, 322199

    Gongqiang Wu, 13757950788

    Not yet recruiting

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi, 341004

    Yijian Chen, 13576749402

    Not yet recruiting

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

    Guangzhou, Guangdong

    Zhongjun Xia

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

    Qingshun Wang

    Recruiting

  • Affiliated Hospital of Guilin Medical College

    Guilin, Guangxi, 541000

    Wenyuan Lin, 15878361619

    Not yet recruiting

  • Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310026

    Jin Zhang

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang

    Jie Jin

    Recruiting

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Qingyuan Zhang

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Kaiyang Ding

    Not yet recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Qingshu Zeng

    Not yet recruiting

  • Shandong Cancer Hospita

    Jinan, Shandong, 250117

    Zengjun Li, 13642138692

    Not yet recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong

    Xin Wang

    Recruiting

  • Jinhua Central Hospital

    Jinhua, Zhejiang, 321000

    Huixian Hu, 13588652288

    Not yet recruiting

  • The first Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Yun Zeng

    Not yet recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

    Liansheng Zhang

    Not yet recruiting

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

    Luoyang, Henan

    Haiping Yang

    Not yet recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Yuerong Shuang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Fei Li

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Jianyong Li

    Wei Xu

    Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejiang

    Guifang Ouyang

    Not yet recruiting

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

    Shanghai, Shanghai Municipality, 200025

    Jianqing Mi

    Not yet recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Yan Li

    Not yet recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Xinyou Zhang

    Not yet recruiting

  • Hebei Medical University Second Hospital

    Shijiazhuang, Hebei, h

    Jinhai Ren

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Lihong Liu

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Zhengming Jing

    Not yet recruiting

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

    Rong Fu

    Recruiting

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

    Lugui Qiu

    Shuhua Yi

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Lihua Qiu

    Yafei Wang

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region, 830011

    Jianhua Qu

    Not yet recruiting

  • Zhongnan Hospital of WuHan University

    Wuhan, Hubei, 430071

    Fuling Zhou

    Not yet recruiting

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

    Wuhan, Hubei

    Guohui Cui

    Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu

    Xin Zhou

    Not yet recruiting

  • The Second Affiliated Hospital of Xi´an Jiaotong University

    Xi’an, Shanxi, 710000

    Aili, He

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Bing Xu

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Zhenyu Li

    Not yet recruiting

  • Subei People's Hospital

    Yangzhou, Jiangsu

    Jian Gu

    Not yet recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan

    Shihua Huang

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei

    Jingming Guo

    Recruiting

  • Yichang First People's Hospital

    Yichang, Hubei

    Kaibo Gao

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Mingzhi Zhang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Keshu Zhou

    Recruiting

  • Henan Province Hospital

    Zhengzhou, Henan

    Zunmin Zhu

    Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

    Guoyu Hu, 13707333899

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
ICP-022, Chlorambucil, Rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-022Drug

    ICP-022 at a dose of 150mg, QD

  • ChlorambucilDrug

    0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6

  • RituximabDrug

    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)

Study groups in NCT04578613
Study groupRoleWhat they receive
ICP-022ExperimentalICP-022 will be orally administered until disease progression or unacceptable toxicity.
Receives: Drug: ICP-022
Chlorambucil combined with RituximabActive comparatorChlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
Receives: Drug: Chlorambucil; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Measured: Up to 5 years

  2. Duration Of Response (DOR)

    Measured: Up to 5 years

  3. Overall Survival (OS)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start8 Jan 2021
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04578613
Sponsor's protocol ID
ICP-CL-00111
Status last verified
May 2023
First submitted
1 Oct 2020
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li F, Zhou K, Xu W, Cui G, Yi S, Jin J, Zhu Z, He A, Mi J, Xia Z, Huang X, Zhou X, Yu W, Guo J, Zeng Q, Huang S, Shuang Y, Peng H, Qiu L, Xu B, Li Y, Yang Y, Zhou F, Wang Y, Liu L, Ren J, Li Y, Yang W, Gu J, Ouyang G, Hua L, Zhang J, Xiao Q, Wang S, Zhang Q, Liu J, Ding K, Zhang L, Zeng Y, Li Z, Wen Q, Gao K, Yang H, Jiang Y, Chen Y, Li Z, Tang X, Wang W, Zhao R, Qiu L, Li J. Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial. Signal Transduct Target Ther. 2026 Jul 6;11(1):261. doi: 10.1038/s41392-026-02818-x.

    PubMed 42402625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ICP-022, Chlorambucil and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 56 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact April Huang (010-66609723, April.huang@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in