RecruitingPhase 2NCT06940791

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

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

Sponsor

Kyorin University

Enrollment

92 participants

Start Date

Oct 6, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether tirabrutinib (a targeted pill) taken as maintenance therapy — to prevent relapse — is better than a placebo for patients with primary central nervous system (CNS) lymphoma who have achieved complete remission after chemotherapy. **You may be eligible if...** - You have been newly diagnosed with primary CNS lymphoma (a type of brain lymphoma) - You have achieved a complete response (no visible cancer) after standard chemotherapy - You are 18 or older with a good performance status (ECOG 0–2) - Your lymphoma is confined to the brain and/or spinal cord (no systemic lymphoma) **You may NOT be eligible if...** - Your lymphoma has spread outside the CNS - You have already received prior therapy for CNS lymphoma - You have severe organ impairment or active infections - You have not completed the required initial chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.