drugset / Trial / NCT07405255

Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma

NCT07405255

Phase 2 Not yet recruiting 19 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

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the mid-term or final assessment: If the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.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

Timeline

Start
2026-01-30
Primary completion
2027-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MTX Unknown 3.5 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Selinexor Other / unclassified 40 mg Oral
Subject Zanubrutinib Small molecule 160 mg Oral

Indications