drugset / Trial / NCT04947319
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)
Timeline
- Start
- 2021-12-29
- Primary completion
- 2026-01-27
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirabrutinib | Small molecule | 320 mg | Oral |
| Subject | Tirabrutinib | Small molecule | 480 mg | Oral |