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RECRUITING
NCT06940791
PHASE2

Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)

Sponsor: Kyorin University

View on ClinicalTrials.gov

Summary

A double-blind, randomized phase II comparative trial will evaluate the superiority of the investigational treatment (tirabrutinib maintenance therapy) over standard care (observation with placebo) in terms of progression-free survival in patients with newly diagnosed primary central nervous system lymphoma (PCNSL) who have achieved complete response (CR or CRu) following induction therapy with high-dose methotrexate (HD-MTX)-based chemotherapy and have not undergone consolidative whole-brain irradiation. Participants will: Take protocol drug tirabrutinib or a placebo every day until disease progression or experience of unacceptable toxicity. Visit the clinic once every 4 weeks for checkups and tests, as well as protocol drug prescription.

Official title: Tirabrutinib Maintenance Versus Placebo in Patients With Primary Central Nervous System Lymphoma in Complete Remission: a Randomized Phase II Study (JCOG2104)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-10-06

Completion Date

2030-02

Last Updated

2025-04-23

Healthy Volunteers

No

Interventions

DRUG

Tirabrutinib

Tirabrutinib (480 mg) taken orally daily at fasting condition

DRUG

Placebo

Placebo taken orally daily at fasting condition

Locations (1)

Kyorin University Hospital

Tokyo, Japan