Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Lymphoma, Mantle-Cell

Study type: Observational

Funder types: Industry

Identifiers

NCT03053024

CR108287

26866138MCL4001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

Cohort 1: Relapse/refractory MCL (rrMCL ) Participants

Description:

Participants characteristics and treatment pattern of relapsed/refractory mantel cell lymphoma \[rrMCL\]) participants treated by Bortezomib (BTZ) will be observed for cohort 1.

Cohort 2: Newly Diagnosed MCL Participants

Description:

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.