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

Not Applicable

Recruiting

• Conditions: Relapsed or refractory Primary CNS Lymphoma; Primary CNS lymphoma; D008228

• Registration Number: JPRN-jRCT1021230006
• Lead Sponsor: agane Motoo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 206

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified