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

Conditions

Relapsed or refractory Primary CNS Lymphoma Primary CNS lymphoma

Fumiyuki Yamasaki, Kazuhiko Mishima, Manabu Natsumeda, Fumiharu Ohka, Hajime Yonezawa et al. (21 authors)

Neuro-Oncology Advances2025-12-01

CTNI-16. PATIENT BACKGROUNDS ASSOCIATED WITH THE PROLONGED EFFECTIVENESS OF TIRABRUTINIB IN PATIENTS WITH RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA: RESULTS FROM THE ROSETTA STUDY

Fumiyuki Yamasaki, Kazuhiko Mishima, Manabu Natsumeda, Fumiharu Ohka, Hajime Yonezawa et al. (21 authors)

Neuro-Oncology2025-11-01

10.1093/neuonc/noaf201.0513

Interim Analysis Data from Multi-Center Retrospective Observational Study of Effectiveness, Safety, and Treatment Status of Tirabrutinib in 161 Japanese Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma: Rosetta Study

Motoo Nagane, Manabu Natsumeda, Fumiharu Ohka, Fumiyuki Yamasaki, Hajime Yonezawa et al. (21 authors)

Blood2024-11-05

10.1182/blood-2024-198558

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
BOR, TTR, TTP, OS subgroup analysis, PFS subgroup analysis, BOR subgroup analysis	—

Contacts

Public ContactShoko Tsutsumi

Mebix, Inc.

ROSETTA@mebix.co.jp+81-3-4362-4504

Outcome results