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

Ono Pharmaceuticals logo

Ono Pharmaceuticals

Status and phase

Enrolling
Phase 1

Conditions

Primary Central Nervous System Lymphoma

Treatments

Drug: Vincristine
Drug: ONO-4059
Drug: Procarbazine
Drug: Methotrexate
Drug: Rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06541665
ONO-4059-13

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental group
Treatment:
Drug: Rituximab
Drug: Methotrexate
Drug: Procarbazine
Drug: ONO-4059
Drug: Vincristine

Trial contacts and locations

26

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Central trial contact

Ono Pharmaceutical Co., Ltd.

Data sourced from clinicaltrials.gov

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