Primary Central Nervous System Lymphoma
Conditions
Brief summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Interventions
DRUGONO-4059
Specified dose, once daily
DRUGRituximab
Specified dose on specified days
DRUGMethotrexate
Specified dose on specified days
DRUGProcarbazine
Specified dose on specified days
DRUGVincristine
Specified dose on specified days
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with PCNSL * Patients who have not received treatment for PCNSL in the past * Patients with ECOG Performance Status 0-2 * Patients expected to survive for 6 months or more
Exclusion criteria
* Patients with intraocular PCNSL without brain lesions * Patients are unable to swallow oral medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability evaluation | 29 Days | The number of subjects who experienced adverse events and side effects will be tallied. In the tolerability evaluation part, the number of subjects who experienced Dose Limiting Toxicity(DLT) will be tallied |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction | 2 years | Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to response (TTR) | 1 year | Time to response is defined as the time between the date of first administration of tirabrutinib and the date of first response (CR, CRu, or PR) as determined by IRC according to the IPCG criteria. |
| Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing | 30days | — |
| Complete response rate (CRR) | 4 months | Complete response rate is defined as the proportion of patients with a best overall response of CR or CRu as determined by an independent review committee according to the IPCG criteria. |
| Best overall response (BOR) | 1 year | Best overall response based on independent review committee (IRC) response determination is defined as the best response and is derived programmatically based upon the visit responses determined by IRC from the date of administration of tirabrutinib to the date of PD as determined by IRC or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first. |
| Duration of response (DOR) | 2 years | Duration of response is defined as the time between the date of first response (Complete response (CR), Complete response - unconfirmed (CRu), or partial response (PR) ) and the date of the first progressive disease(PD) according to the IPCG criteria, or date of death due to any cause, whichever occurs first. |
Countries
Japan
Outcome results
None listed