Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyorin University
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 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 criteria
This trial does not accept healthy volunteersQualifiers
Histopathological diagnosis of B cell lymphoma.
Newly-diagnosed PCNSL confined to the cerebrum, cerebellum and brainstem. Patients with or without interocular lymphoma are eligible.
Negative cerebrospinal fluid (CSF) cytology, or no evidence of leptomeningeal lymphomatosis in contrast-enhanced magnetic resonance imaging (MRI) of the brain and the whole spinal cord.
No evidence of systemic lymphoma before induction chemotherapy, confirmed by contrast-enhanced CT including the neck, chest, abdomen, pelvic cavity and groin, or whole-body positron-emission tomography (PET) and CT.
Disqualifiers
Synchronous or metachronous malignancies.
Infections requiring systemic treatment at the time of registration.
Body temperature >=38 degree celsius at the time of registration.
Serious lung disorders, such as interstitial pneumonia, obstructive lung disease, hypersensitive pneumonitis, symptomatic bronchospasm) at the time of registration.
Trial design
Design model
Parallel
Treatments tested in this trial
Tirabrutinib
DrugTirabrutinib (480 mg) taken orally daily at fasting condition
Placebo
DrugPlacebo taken orally daily at fasting condition
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Standard armPlacebo comparator 1 intervention
Group B: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) based on independent review committee (IRC) assessment
Time frame
From the date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 78 monthsSecondary outcomes
1
Progression-free survival (PFS) determined by investigator
Time frame
From the date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 78 months2
Overall survival (OS)
Time frame
From the date of registration until the date of death from any cause, assessed up to 78 months3
PFS/OS in the maintenance per protocol group
Time frame
PFS: From the date of registration until the date of first progression or date of death from any cause, whichever came first, assessed up to 78 months. OS: From the date of registration until the date of death from any cause, assessed up to 78 months.4
PFS/OS by the induction therapy regimen with or without consolidation therapy
Time frame
PFS: From the date of registration until the date of first progression or date of death from any cause, whichever came first, assessed up to 78 months. OS: From the date of registration until the date of death from any cause, assessed up to 78 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kyorin University
Lead sponsor
National Cancer Center, Japan
Collaborator
Ono Pharmaceutical Co., Ltd.
Collaborator
Japan Clinical Oncology Group
Collaborator
Source ClinicalTrials.gov