Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
- Conditions
- Relapsed/Refractory Primary Central Nervous System Lymphoma
- Interventions
- Registration Number
- NCT07104032
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 132
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirabrutinib Tirabrutinib Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles. Rituximab-Temozolomide (R-TMZ) Rituximab Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6. Rituximab-Temozolomide (R-TMZ) Temozolomide Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Estimated up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Estimated up to 48 months] 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).
Overall Survival (OS) Estimated up to 48 months OS defined as time from randomization until death due to any cause.
Complete Response Rate (CRR) Estimated up to 48 months CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu.
Best Overall Response (BOR) Estimated up to 48 months] 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 to Response (TTR) Estimated up to 48 months TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR.
Time to Complete Response (TTCR) Estimated up to 48 months TTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu).
Duration of Response (DOR) Estimated up to 48 months 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.
Disease Free Survival (DFS) Estimated up to 48 months 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.
Change from Baseline in Corticosteroid Dose Baseline, estimated up to 48 months