Clinical trial · Observational
Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants
An Observational Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in China
NCT03053024CI-TRIAL-00048159completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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.
- label
- 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.
Primary outcomes (10)
- measure
- Demographic Characteristic of Participants in Prospective Group: Age
- timeFrame
- Baseline
- description
- Continuous variable (age) will be summarized using descriptive statistics.
- measure
- Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.