Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
NCT ID: NCT06940791
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
92 participants
INTERVENTIONAL
2023-10-06
2030-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
NCT07104032
RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor
NCT03536039
A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
NCT03650933
Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
NCT06422247
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
NCT00147121
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard arm
Observation with placebo
Placebo
Placebo taken orally daily at fasting condition
Experimental arm
Tirabrutinib maintenance therapy
Tirabrutinib
Tirabrutinib (480 mg) taken orally daily at fasting condition
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tirabrutinib
Tirabrutinib (480 mg) taken orally daily at fasting condition
Placebo
Placebo taken orally daily at fasting condition
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 lymphomatosis in contrast-enhanced magnetic resonance imaging (MRI) of the brain and the whole spinal cord.
4. 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.
5. Patients with a single lesion, or multiple lesions, are eligible.
6. Patients 18 years old or older at the time of registration.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, 2.
8. Have completed either of the following methotrexate (MTX)-based chemotherapy i) R-MPV (rituximab, MTX, procarbazine and vincristine) ii) MPV (MTX, procarbazine and vincristine) iii) R-MP (rituximab, MTX and procarbazine) iv) MP (MTX and procarbazine) v) R-M (rituximab and MTX) vi) MTX monotherapy
9. Complete response (CR) or complete response unconfirmed (CRu) based on the International PCNSL Collaborative Group (IPCG) criteria.
10. Within 60 days from the last dose of induction or consolidation chemotherapy.
11. No treatment history of radiotherapy for PCNSL.
12. Refused to receive consolidation radiotherapy.
13. No treatment history of chemotherapy or radiotherapy, except for stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) for non-cancer diseases (such as arteriovenous malformations).
14. Adequate organ function. i) Neutrophil count \>=1,000/mm3 ii) Hemoglobin \>= 8.0 g/dl iii) Platelet count \>= 75,000/mm3 iv) AST \<=120 U/L v) ALT \<= 120 U/L vi) Total Bilirubin \<= 2.25 mg/dl vii) Creatinine \<= 1.5 mg/dL
15. Written informed consent.
Exclusion Criteria
2. Infections requiring systemic treatment at the time of registration.
3. Body temperature \>=38 degree celsius at the time of registration.
4. Serious lung disorders, such as interstitial pneumonia, obstructive lung disease, hypersensitive pneumonitis, symptomatic bronchospasm) at the time of registration.
5. History or presence of aspergillus pneumonitis or pneumocystis pneumonia.
6. History of serious drug allergy or serious anaphylaxis.
7. Heart failure (\>= III in New York Heart Association functional classification), unstable angina pectoris, or history of myocardial infarction within the preceding 180 days prior to registration.
8. Treated by anticoagulants at the time of registration.
9. Treated by antiplatelets at the time of registration.
10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
11. Immune deficiency, such as acquired immunodeficiency syndrome (AIDS), X-linked agammaglobulinemia, chronic granulomatous disease, Wiskott-Aldrich syndrome, or any other iatrogenic immunosuppressive conditions.
12. Post organ transplant immunosuppression.
13. Prednisone use of \>10 mg/day for condition other than intracranial tumor, or regular use of immunosuppressants.
14. Uncontrolled diabetes mellitus.
15. Treated either by CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inducers within 14 days prior to registration.
16. Gadolinium allergy.
17. Positive HIV antibody.
18. Positive HBs antigen.
19. Positive HBs antibody or HBc antibody, and HBV-DNA positive.
20. Positive HCV antibody.
21. Unable to take oral medicine,
22. Females during pregnancy, or within 28 days postpartum, or during lactation. Males who wish childbearing of his partner.
23. Prior history of treatment by BTK inhibitors.
24. Severe psychiatric disorders.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Center, Japan
OTHER_GOV
Ono Pharmaceutical Co. Ltd
INDUSTRY
Japan Clinical Oncology Group
OTHER
Kyorin University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Motoo Nagane
Professor, Department of Neurosurgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kyorin University Hospital
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JCOG2104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.