Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Ono Pharmaceutical Co. Ltd

Conditions:

Primary Central Nervous System Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • Patients with intraocular PCNSL without brain lesions
  • Patients are unable to swallow oral medications

Key Trial Info

Start Date :

May 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2028

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06541665

Start Date

May 17 2024

End Date

August 31 2028

Last Update

June 3 2025

Active Locations (44)

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Page 1 of 11 (44 locations)

1

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

2

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

3

Akita University Hospital

Akita, Akita, Japan

4

Juntendo University Urayasu Hospital

Urayasu-shi, Chiba, Japan