Status:
RECRUITING
Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
Lead Sponsor:
Kyorin University
Collaborating Sponsors:
National Cancer Center, Japan
Ono Pharmaceutical Co. Ltd
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- Patients with a single lesion, or multiple lesions, are eligible.
- Patients 18 years old or older at the time of registration.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, 2.
- 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
- Complete response (CR) or complete response unconfirmed (CRu) based on the International PCNSL Collaborative Group (IPCG) criteria.
- Within 60 days from the last dose of induction or consolidation chemotherapy.
- No treatment history of radiotherapy for PCNSL.
- Refused to receive consolidation radiotherapy.
- No treatment history of chemotherapy or radiotherapy, except for stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) for non-cancer diseases (such as arteriovenous malformations).
- 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
- Written informed consent.
Exclusion
- 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.
- History or presence of aspergillus pneumonitis or pneumocystis pneumonia.
- History of serious drug allergy or serious anaphylaxis.
- 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.
- Treated by anticoagulants at the time of registration.
- Treated by antiplatelets at the time of registration.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
- Immune deficiency, such as acquired immunodeficiency syndrome (AIDS), X-linked agammaglobulinemia, chronic granulomatous disease, Wiskott-Aldrich syndrome, or any other iatrogenic immunosuppressive conditions.
- Post organ transplant immunosuppression.
- Prednisone use of \>10 mg/day for condition other than intracranial tumor, or regular use of immunosuppressants.
- Uncontrolled diabetes mellitus.
- Treated either by CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inducers within 14 days prior to registration.
- Gadolinium allergy.
- Positive HIV antibody.
- Positive HBs antigen.
- Positive HBs antibody or HBc antibody, and HBV-DNA positive.
- Positive HCV antibody.
- Unable to take oral medicine,
- Females during pregnancy, or within 28 days postpartum, or during lactation. Males who wish childbearing of his partner.
- Prior history of treatment by BTK inhibitors.
- Severe psychiatric disorders.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06940791
Start Date
October 6 2023
End Date
February 1 2030
Last Update
April 23 2025
Active Locations (1)
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1
Kyorin University Hospital
Tokyo, Japan, 181-8611