NCT06714370
Not yet recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL)
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 35
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is ≥ 18 years of age.
- •r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June
- •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.
- •Histopathologically confirmed large B-cell PCNSL.
- •Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX.
- •Exclude HIV infection
- •Exclude Burkitt lymphoma
- •Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: At least 9 months for each subject
objective response rate is defined as the proportion of subjects who respond either Complete response (CR), Partial response (PR), or unconfirmed Complete response (CRu) to therapy, according to International PCNSL Collaborative Group (IPCG) criteria.
Secondary Outcomes
- Duration of response (DOR)(At least 9 months for each subject)
- Time-to-treatment response (TTR)(At least 9 months for each subject)
- Adverse events of special interest (AESIs)(At least 9 months for each subject)
- Clinical laboratory test(At least 9 months for each subject)
- Treatment-emergent adverse events (TEAEs)(At least 9 months for each subject)
- Overall survival (OS)(At least 9 months for each subject)
- Progression-free survival (PFS)(At least 9 months for each subject)
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