Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06541665
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONO-4059 — DRUG
    Specified dose, once daily
  • Rituximab — DRUG
    Specified dose on specified days
  • Methotrexate — DRUG
    Specified dose on specified days
  • Procarbazine — DRUG
    Specified dose on specified days
  • Vincristine — DRUG
    Specified dose on specified days

Study Details

To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.

Key Dates

Start date
May 17, 2024
Status verified
May 2025
Primary completion
Apr 28, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL

Primary Outcome Measure

Tolerability evaluation [ Time Frame: 29 Days ]

Related Studies