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PhII Study of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma

Daniela Bota


A Study On:

  • Brain and Nervous System

Status:

  • Open

Eligibility

Adults

Interested in joining this trial?

Official Title

An Open-Label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinectics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma (PCNSL)

Details

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/ temozolimide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)


Eligibility

You can join if...

Inclusion Criteria:

  • Pathologically diagnosed with Primary Central Nervous System Lymphoma
  • Life expectancy of at least 3 months (part A) or at least 6 months (part B)
  • Adequate bone marrow, renal, and hepatic function as described by the study protocol

Exclusion Criteria:

  • Patient who is intolerant of contrast-enhanced MRI due to allergic reactions to contrast agents
  • Patient with systemic presence of lymphoma
  • Prior radiotherapy within 14 days before starting tirabrutinib (study drug) treatment

Get in touch with our study team