An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: D'Angelo, Christopher
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04947319?term=NCT04947319&draw=2&rank=1#eligibility
Summary
PART A
Primary objective
To evaluate the efficacy of tirabrutinib monotherapy in patients with R/R PCNSL
Secondary objectives
To evaluate the efficacy of tirabrutinib monotherapy in patients with R/R PCNSL
To evaluate the safety of tirabrutinib monotherapy in patients with R/R PCNSL
To evaluate the PK of tirabrutinib monotherapy in patients with R/R PCNSL
Tertiary/exploratory objectives
To evaluate the efficacy of tirabrutinib monotherapy in patients with R/R PCNSL
To evaluate the safety of tirabrutinib when taken concomitantly with moderate or strong cytochrome P450 3A4
(CYP3A4) inhibitors (e.g., azole antifungal drugs) To evaluate the PK of tirabrutinib when taken concomitantly with
moderate or strong CYP3A4 inhibitors (e.g., azole antifungal drugs)
To evaluate exploratory biomarkers in patients with R/R PCNSL
PART B
Primary objective
To evaluate the safety of tirabrutinib during induction when administered in combination with MTR and R-MPV induction regimens in newly diagnosed, treatment-naïve patients with PCNSL
To evaluate the CRR for each treatment arm according to IPCG criteria based on IRC response determination in newly diagnosed, treatment-naïve patients with PCNSL Secondary objectives
To evaluate the safety of tirabrutinib when administered as monotherapy in patients receiving tirabrutinib post-induction To evaluate the efficacy of tirabrutinib in combination with MTR and R-MPV induction regimens in newly diagnosed, treatment-naïve patients with PCNSL
To evaluate the PK of tirabrutinib in combination with MTR and R-MPV induction regimens
To evaluate the PK of methotrexate in the tirabrutinib plus MTR induction regimen and that of methotrexate and vincristine in the tirabrutinib plus R-MPV induction regimen
Tertiary/exploratory objectives
To assess exploratory biomarkers in patients with newly diagnosed PCNSL