RecruitingPhase IIEN originalLymphoma

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rozpoznaniem histopatologicznym chłoniaka typu B
  • Nowo wykryty chłoniak ograniczony do mózgu, móżdżku lub pnia mózgu
  • Brak raka poza mózgiem potwierdzone badaniami obrazowymi
  • Ukończona chemioterapia na bazie metotreksatu z całkowitą remisją
  • Wiek 18 lat lub więcej
  • Dobre ogólne samopoczucie (możliwość codziennych aktywności)
  • Prawidłowe funkcje nerek, wątroby i szpiku kostnego
  • Świadoma zgoda na udział w badaniu

✗ Disqualifies

  • Obecny lub przeszły inny nowotwór
  • Wcześniejsza radioterapia mózgu z powodu chłoniaka
  • Poważne infekcje wymagające leczenia systemowego

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 5, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Kyorin University Hospital

Tokyo, Japan

Trial contact

Nobuyoshi Sasaki, M.D., Ph.D.

Motoo Nagane, M.D., Ph.D.

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/6/2026.

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