A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
NCT ID: NCT06363994
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
476 participants
INTERVENTIONAL
2024-05-29
2032-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Arm B
Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Interventions
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Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Eligibility Criteria
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Inclusion Criteria
2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
3. Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
4. At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm).
5. ECOG PS score of 0 to 2.
Exclusion Criteria
2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
5. Known central nervous system lymphoma.
60 Years
ALL
No
Sponsors
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InnoCare Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, , China
First Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
The First People's Hospital of Changzhou
Changzhou, , China
Sichuan Provincial People's Hospital
Chengdu, , China
West China Hospital of Sichuan University
Chengdu, , China
Chongqinq Cancer Hospital
Chongqing, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
The second Hospital of Dalian Medical University
Dalian, , China
Fujing Cancer Hospital
Fuzhou, , China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang University Medical School affiliated to the first Hospital
Hangzhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Cancer Hospital of Shandong First Medical University
Jinan, , China
Shandong Provincial Hospital
Jinan, , China
The First Affiliated Hospital of Ningbo University
Jinan, , China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, , China
Cancer Hospital Affiliated to Fudan University
Shanghai, , China
Huashan Hospital of Fudan University
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Cancer Hospital
Taiyuan, , China
Tianjin Cancer Hospital
Tianjin, , China
The Tumor Hospital Affiliated to Xinjiang Medical University
Ürümqi, , China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, , China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, , China
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xi'an, , China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, , China
Yibin Second People's Hospital
Yibin, , China
Henan Cancer Hospital
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yuqin Song
Role: primary
Hongmei Jing
Role: primary
Yanli Yang
Role: primary
Ou Bai
Role: primary
Hui Zhou
Role: primary
Weiying Gu
Role: primary
Xiaobing Huang
Role: primary
Liqun Zhou
Role: primary
Yingyu Nan
Role: primary
Xiaoqiong Tang
Role: primary
Xiuhua Sun
Role: primary
Hongming He
Role: primary
Tingbo Liu
Role: primary
Wenyu Li
Role: primary
Zhiming Li
Role: primary
Wenbin Qian
Role: primary
Wenjuan Yu
Role: primary
Jian Ge
Role: primary
Zengjun Li
Role: primary
Xiaosheng Fang
Role: primary
Guifang Ouyang
Role: primary
Ling Qin
Role: primary
Fei Li
Role: primary
Jingyan Xu
Role: primary
Qunling Zhang
Role: primary
Yan Yuan
Role: primary
Aijun Liao
Role: primary
Xiaojing Yan
Role: primary
Lihong Liu
Role: primary
Liping Su
Role: primary
Zhengzi Qian
Role: primary
Shujuan Wen
Role: primary
Liling Zhang
Role: primary
Jia Kui
Role: primary
Guangxun Gao
Role: primary
Wanhong Zhao
Role: primary
Shihua Huang
Role: primary
Keshu Zhou
Role: primary
Zunmin Zhu
Role: primary
Other Identifiers
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ICP-CL-00128
Identifier Type: -
Identifier Source: org_study_id