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

NCT06940791 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tirabrutinib

Tirabrutinib (480 mg) taken orally daily at fasting condition

DRUG

Placebo

Placebo taken orally daily at fasting condition

Sponsors & Collaborators

  • National Cancer Center, Japan

    collaborator OTHER_GOV

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Japan Clinical Oncology Group

    collaborator OTHER

  • Kyorin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2030-02-28
Completion
2030-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940791 on ClinicalTrials.gov