Clinical trial · Observational
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
NCT06714370CI-TRIAL-00112129REVEALcompletedClinicalTrials.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 goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.
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 |
|---|---|---|---|
| Primary Central Nervous System Lymphoma (PCNSL) | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- At least 9 months for each subject
- description
- 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 (7)
- measure
- Duration of response (DOR)
- timeFrame
- At least 9 months for each subject
- description
- Duration of response is defined as the time from onset of response\* to disease progression or death, wichever occurs earlier. \*for patients who achieve complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.
- measure
- Time-to-treatment response (TTR)
- timeFrame
- At least 9 months for each subject
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 lacks the capacity to give informed consent. 4. Deceased patients are considered included under an IRB-approved consent waiver. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.