An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)
Primary Objective
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)
Description
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)
Details
Locations
CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital
Principal Investigator
Denise M. Damek
Study ID
Protocol Number: 21-4778
More information available at ClinicalTrials.gov: NCT04947319
Categories
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