A multi-center retrospective observational study of effectiveness, safety and treatment status of tirabrutinib in relapsed or refractory pcnsl (ROSETTA)

JRCT ID: jRCT1021230006

Registered date:21/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or refractory Primary CNS Lymphoma
• Date of first enrollment: 06/04/2023
• Target sample size: 206
• Study type: Observational

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: BOR, TTR, TTP, OS subgroup analysis, PFS subgroup analysis, BOR subgroup analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients diagnosed with relapsed or refractory PCNSL and started initial treatment with tirabrutinib between November 1, 2020 and April 30, 2022, and who were enrolled in a Post Marketing Surveillance

Exclude criteria

1. Patients with PCNSL who had not recieved drug therapy
2. Patients with metastasis outside the central nervous system, excluding intraocular, at the time of starting the first tirabrutinib treatment
3. Patients diagnosed with secondary central nervous system lymphoma (SCNSL)
4. Patients who had participated in clinical studies involving other interventions between the first PCNSL diagnosed and the start of the first tirabrutinib treatment. However, among patients who had participated in clinical research involving intervention, patients who recieved treatment within the indications of PCNSL treatment can be enrolled in this study.
5.Patients who weren't perscribed 480 mg of tirabrutinib once daily in fasted condition at the start of treatment

Related Information

• Primary Sponsor: Nagane Motoo
• Secondary Sponsor: Matsumoto Hiroki,ONO PHAMACEUTICAL CO., LTD.,ONO PHAMACEUTICAL CO., LTD.