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

Recruiting Phase 2 Interventional Study
Primary Central Nervous System Lymphoma
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Kyorin University · Other
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About This 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 hi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histopathological diagnosis of B cell lymphoma. 2. Newly-diagnosed PCNSL confined to the cerebrum, cerebellum and brainstem. Patients with or without interocular lymphoma are eligible. 3. Negative cerebrospinal fluid (CSF) cytology, or no evidence of leptomeningeal lymphomato…
Contacts

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

+81422475511

sasakinobuyoshi0308@gmail.com

CONTACT

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

+81422475511

mnagane@ks.kyorin-u.ac.jp

CONTACT