PCNSL Prospect Study
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Now Enrolling
PROSPECT Study in Primary Central Nervous System Lymphoma
Current treatment options for primary central nervous system lymphoma (PCNSL) are limited, and there are no medications approved specifically for the treatment of PCNSL in the United States.
The PROSPECT Study, sponsored by ONO Pharma USA, provides an investigational therapeutic option for the treatment of both newly diagnosed and relapsed/refractory PCNSL. The investigational product, tirabrutinib, is approved and is currently marketed in Japan for R/R PCNSL. Tirabrutinib is currently not FDA-approved for any use in the United States. This study is enrolling now at 43 study sites across the United States.
PROSPECT Study
The PROSPECT Study (NCT04947319) is an open-label, Phase 2 trial to evaluate the efficacy, safety, and pharmacokinetics of:
- Tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A)
- 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)