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
Qualifiers
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
Treatments tested in this trial
- Tirabrutinib
- Placebo
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kyorin University
Lead sponsor
National Cancer Center, Japan
Collaborator
Ono Pharmaceutical Co., Ltd.
Collaborator
Japan Clinical Oncology Group
Collaborator
Source ClinicalTrials.gov