Clinical trial NCT03053024: Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants
Official title: An Observational Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Mantle-Cell
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study include mantle cell lymphoma (MCL) participants who were or will be treated by Bortezomib (BTZ) per routine clinical care in multiple tertiary care hospitals after January 1st 2009. Both newly diagnosed MCL participants and relapsed/refractory MCL participants will be included.

Brief summary: The purpose of the study (retrospective and prospective) is to describe participant and disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma (MCL) participants in China.


Eligibility criteria: Inclusion Criteria:

* Participants that have been hospitalized for MCL after January 1st 2009.
* 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 with documented diagnosis of other cancers prior to or at the presence of the diagnosis of MCL
* 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

Primary outcomes:
measure: Demographic Characteristic of Participants in Prospective Group: Age
timeFrame: Baseline
measure: Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline
measure: Ann Arbor Stage
timeFrame: Up to Follow-up (approximately 22 months)
measure: Prognostic Index Score
timeFrame: Baseline
measure: Demographic Characteristic of Participants in Prospective Group: Gender
timeFrame: Baseline
measure: Treatment pattern of BTZ-treated MCL participants: Route of Administration
timeFrame: Up to Follow-up (approximately 22 months)
measure: Treatment Pattern of Bortezomib (BTZ) Treated MCL participants: Dose
timeFrame: Up to Follow-up (approximately 22 months)
measure: Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Frequency
timeFrame: Up to Follow-up (approximately 22 months)
measure: Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Reason of BTZ Initiation/Discontinuation/Dose Adjustment
timeFrame: Up to Follow-up (approximately 22 months)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 22 months
measure: Complete Response [CR] Rate (CR+ Unconfirmed Complete Remission CRu)
timeFrame: Approximately 22 months
measure: Partial Remission (PR) Rate
timeFrame: Approximately 22 months
measure: Time to Response (TTR)
timeFrame: Approximately 22 months
measure: Duration of Response (DOR)
timeFrame: Approximately 22 months
measure: Progressive-Free Survival (PFS)
timeFrame: Approximately 22 months
measure: Overall survival (OS)
timeFrame: Approximately 22 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: NanJing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Tianjin
country: China
facility: Blood Disease Hospital of Chinese Academy of Medical Sciences
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: