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

NCT06714370 | Not Yet Recruiting

• 1 other identifier: R1128-TIR-04
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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.

  At least 9 months for each subject

Secondary Outcomes (7)

• 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

Other Outcomes (3)

• ECOG Performance Status Scale

  At least 9 months for each subject

• Clinical usage and pattern of tirabrutinib

  At least 9 months for each subject

• Ratio of the premedications for infection and skin-related disorders

  At least 9 months for each subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient received Taiwan NHI reimbursement

You may qualify if:

• 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 2025.
• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Central Study Contacts

Scientific Advisor

CONTACT

886-2-8786-9750; lyla.hsu@ono-pharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL