Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: a Nationwide Study

Study Purpose

The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient is ≥ 18 years of age. 2. r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June 2025. 3. Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who has died or lacks the capacity to give informed consent.Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received. 1. Histopathologically confirmed large B-cell PCNSL. 2. Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX. 3. Exclude HIV infection. 4. Exclude Burkitt lymphoma. 5. Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06714370
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ono Pharmaceutical Co. Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Central Nervous System Lymphoma (PCNSL)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Scientific Advisor

[email protected]

886-2-8786-9750

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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