Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma (NCT07405255) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma
China19 participantsStarted 2026-01-30
Plain-language summary
Subjects who met the inclusion/exclusion criteria were included in the experimental group after signing the informed consent form. One course of Z(R)-MTX(TMZ) treatment was given. After the results of the second-generation sequencing were reported, selinisol was added to the original treatment plan for those with TP53 mutations, and the original treatment plan was continued for those without TP53 mutations. Each course of treatment lasts for three weeks. A mid-term assessment is conducted after three courses of treatment, and a final assessment is carried out after six courses of treatment. After the mid-term or final assessment:
If the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.
If the subjects achieve CR or PR, they enter maintenance treatment and continue with zanubrutinib for 2 years. For young patients (\< 65 years old), they can choose whether to receive ASCT as consolidation treatment according to their personal will, and then follow up and observe until 3 years have passed.
SD/PD patients receive subsequent treatment after being judged by the researchers
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a full understanding of this study and voluntarily sign the informed consent form.
* Untreated patients with primary central nervous system lymphoma (PCNSL) confirmed by pathology (immunotyping) according to the 2016 WHO classification of lymphoid neoplasms.
* Diffuse large B-cell lymphoma (DLBCL) originating from the central nervous system (CNS) without involvement of other organs, confirmed by PET-CT or contrast-enhanced CT.
* Expected survival greater than 3 months.
* Laboratory test results meeting all of the following:
* Creatinine clearance rate ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
* International normalized ratio (INR) ≤ 1.5 × ULN or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on warfarin may have INR 2-3.
* Left ventricular ejection fraction (LVEF) ≥ 50%.
* Glomerular filtration rate (GFR) ≥ 60 mL/min.
* Male or female patients of childbearing potential must agree to use effective contraception (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine device) during the study and for 30 days after the last dose.
* Postmenopausal women (\> 45 years old and amenorrheic \> 1 year) or surgically sterilized women are exempt from this requirement.
Exclusion Criteria:
* Contraindication to any drug included in the treatment regimen.
* History of clinically significant liver disease, including viral or other hepatitis or cirrhosis.
* Hepatitis B: Positive hepatitis B surface…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Remission Rate (CRR)
Timeframe: At the end of Cycle 6 and at 4 weeks after completion of Cycle 6 (each cycle is 21 days).