Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
- Conditions
- Primary Central Nervous System Lymphoma
- Interventions
- Registration Number
- NCT06541665
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- Patients with intraocular PCNSL without brain lesions
- Patients are unable to swallow oral medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL ONO-4059 - Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL Methotrexate - Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL Rituximab - Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL Procarbazine - Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL Vincristine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing 30days 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.
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.
Trial Locations
- Locations (44)
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Akita University Hospital
🇯🇵Akita-shi, Akita, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu-shi, Chiba, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health,Japan
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Gifu University Hospital (Tokai National Higher Education and Research System)
🇯🇵Gifu-shi, Gifu, Japan
Scroll for more (34 remaining)Aichi Cancer Center🇯🇵Nagoya-shi, Aichi, Japan