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Compares treatment options for Primary Central Nervous System Lymphoma
Official title Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
ClinicalTrials.gov ID: NCT06940791
What this study is testing
What is Tirabrutinib?
Tirabrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary central nervous system lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No evidence of systemic lymphoma before induction chemotherapy, confirmed by contrast-enhanced CT including the neck, chest, abdomen, pelvic cavity...
- Patients with a single lesion, or multiple lesions, are eligible.
You likely can't join if
- 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...
- History or presence of aspergillus pneumonitis or pneumocystis pneumonia.
- History of serious drug allergy or serious anaphylaxis.
See the full eligibility criteria
- 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...
- 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...
- Written informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.