Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants
NCT ID: NCT03053024
Last Updated: 2020-11-06
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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COMPLETED
54 participants
OBSERVATIONAL
2017-04-14
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Relapse/refractory MCL (rrMCL ) Participants
Participants characteristics and treatment pattern of relapsed/refractory mantel cell lymphoma \[rrMCL\]) participants treated by Bortezomib (BTZ) will be observed for cohort 1.
No interventions assigned to this group
Cohort 2: Newly Diagnosed MCL Participants
Participants characteristics and treatment pattern of newly diagnosed MCL participants (if more than 20% of total BTZ-treated MCL) will be analysed for cohort 2.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Biopsy proven MCL as evidenced by histology with either immunohistochemistry (IHC) or t(11,14) translocation
* Retrospective group: Participants who have finished BTZ treatment before the study initiation as judged by participating site physician
* If participant isn't accessible for oral or written informed consent, ICF can be waived after approved by the IRB
* Prospective group: Participants who are on BTZ at the time of study initiation or start BTZ after study initiation
Exclusion Criteria
* Participants enrolled in interventional clinical trials of BTZ or any other drug for MCL
* Prospective group: Participants with contraindication listed in the prescribing information of BTZ
18 Years
ALL
No
Sponsors
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Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Role: STUDY_DIRECTOR
Xian-Janssen Pharmaceutical Ltd.
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
Nanfang Hospital
Guangzhou, , China
Jiangsu Province Hospital
Nanjing, , China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, , China
Huashan Hospital Fudan University
Shanghai, , China
Blood Disease Hospital of Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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Other Identifiers
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26866138MCL4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108287
Identifier Type: -
Identifier Source: org_study_id