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

Ono Pharmaceutical Co., Ltd.24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung Univeristy Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: At least 9 months for each subject

Secondary Outcomes

Duration of response (DOR)

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.

Time frame: At least 9 months for each subject

Time-to-treatment response (TTR)

Time-to-treatment response was defined as time from newly started tirabrutinib treatment to the first objective tumor response observed for patients who achieved a complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.

Time frame: At least 9 months for each subject

Adverse events of special interest (AESIs)

Drug-related adverse events for treatment interruption, dose reduction, and discontinuation of tirabrutinib: febrile neutropenia (grade≥3), thrombocytopenia with hemorrhage (grade 3), neutropenia (grade 4), thrombocytopenia (grade 4), interstitial lung disease (grade≥2), skin disorder (grade≥2), hematotoxicity (grade≥3, other than events described above) and nonhematological toxicity (other than interstitial lung disease and skin disorder, grade≥3) (the grading will be according to CTCAE v5.0.) important identified risks: infection, severe skin disorder, bone marrow depression, hypersensitivity, interstitial lung disease (ILD), hepatic dysfunction, hemorrhage, arrhythmia.

Time frame: At least 9 months for each subject

Clinical laboratory test

Data from ClinicalTrials.gov

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