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If the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.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 range18 Years – 80 Years
SexALL
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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…
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).