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Clinical Trials/jRCT2071230124
jRCT2071230124
Active, not recruiting
Not Applicable

ONO-4059-13: A Multicenter, phase I, open-label, uncontrolled study of ONO-4059 in combination with rituximab, methotrexate, procarbazine, and vincristine (R-MPV) therapy for Untreated primary central nervous system lymphoma (PCNSL)

Ono Pharmaceutical Co.,LTD0 sites20 target enrollmentMay 17, 2024
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Ono Pharmaceutical Co.,LTD
Enrollment
20
Primary Endpoint
tolerability
Status
Active, not recruiting
Last Updated
11 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
jrct.mhlw.go.jp
Start Date
May 17, 2024
End Date
TBD
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Assignment
Sex
All

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

tolerability

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

safety

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

Secondary Outcomes

  • Pharmacokinetics of ONO-4059
  • Efficacy of ONO-4059

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