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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Central Nervous System Lymphoma (PCNSL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Scientific Advisor

Role: CONTACT

[email protected]

886-2-8786-9750

Other Identifiers

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R1128-TIR-04

Identifier Type: -

Identifier Source: org_study_id