The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Administered orally.
Administered intravenously (IV).
Administered orally.
HonorHealth Cancer Center
Scottsdale, Arizona, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGProgression Free Survival (PFS)
PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Estimated up to 24 months
Overall Response Rate (ORR)
ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR).
Time frame: Estimated up to 48 months]
Overall Survival (OS)
OS defined as time from randomization until death due to any cause.
Time frame: Estimated up to 48 months
Complete Response Rate (CRR)
CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu.
Time frame: Estimated up to 48 months
Best Overall Response (BOR)
BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first.
Time frame: Estimated up to 48 months]
Time to Response (TTR)
TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR.
Time frame: Estimated up to 48 months
Time to Complete Response (TTCR)
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGTTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu).
Time frame: Estimated up to 48 months
Duration of Response (DOR)
DOR based on BIRC per IPCG criteria, defined as the time between the date of first response (CR, CRu, or PR) and the date of the first PD or date of death due to any cause, whichever occurs first.
Time frame: Estimated up to 48 months
Disease Free Survival (DFS)
DFS based on BIRC per IPCG criteria, defined as the time between the date of first complete response (CR or CRu) and the date of the first PD, or date of death due to any cause, whichever occurs first.
Time frame: Estimated up to 48 months
Change from Baseline in Corticosteroid Dose
Time frame: Baseline, estimated up to 48 months