Actively Recruiting
Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
Led by Kyorin University · Updated on 2025-04-23
92
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
K
Kyorin University
Lead Sponsor
N
National Cancer Center, Japan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of B cell lymphoma
- Newly diagnosed PCNSL confined to cerebrum, cerebellum, and brainstem
- Negative cerebrospinal fluid cytology or no leptomeningeal lymphomatosis on MRI
- No evidence of systemic lymphoma confirmed by CT or PET-CT
- Single or multiple lesions allowed
- Age 18 years or older at registration
- ECOG performance status of 0, 1, or 2
- Completed specified methotrexate-based chemotherapy regimens
- Complete response (CR) or complete response unconfirmed (CRu) per IPCG criteria
- Within 60 days from last dose of induction or consolidation chemotherapy
- No prior radiotherapy for PCNSL
- Refused consolidation radiotherapy
- No prior chemotherapy or radiotherapy except stereotactic radiosurgery/radiotherapy for non-cancer diseases
- Adequate organ function tested by blood counts and liver/kidney function
- Provided written informed consent
You will not qualify if you...
- Synchronous or metachronous malignancies
- Infections requiring systemic treatment at registration
- Body temperature 38°C or higher at registration
- Serious lung disorders (interstitial pneumonia, obstructive lung disease, hypersensitive pneumonitis, symptomatic bronchospasm)
- History or presence of aspergillus pneumonitis or pneumocystis pneumonia
- History of serious drug allergy or anaphylaxis
- Heart failure (NYHA class III or higher), unstable angina, or recent myocardial infarction within 180 days
- Use of anticoagulants or antiplatelets at registration
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Immune deficiency conditions including AIDS and other immunosuppressive disorders
- Post organ transplant immunosuppression
- Prednisone use over 10 mg/day for conditions other than intracranial tumor or regular immunosuppressant use
- Uncontrolled diabetes mellitus
- Treatment with CYP3A4 inhibitors, inducers, or P-gp inducers within 14 days prior to registration
- Allergy to gadolinium
- Positive HIV antibody test
- Positive hepatitis B surface antigen or active hepatitis B infection
- Positive hepatitis C antibody
- Unable to take oral medication
- Pregnancy, postpartum within 28 days, lactation in females, or male partners wishing to father a child
- Prior treatment with BTK inhibitors
- Severe psychiatric disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kyorin University Hospital
Tokyo, Japan, 181-8611
Actively Recruiting
Research Team
N
Nobuyoshi Sasaki, M.D., Ph.D.
CONTACT
M
Motoo Nagane, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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