Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital

About this trial

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If the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV-DNA above ULN.

Active hepatitis C: Positive HCV antibody with detectable HCV-RNA.

Trial design

Treatments tested in this trial

  • Zanubrutinib + Rituximab + MTX ± Selinexor

Treatment groups

19 Participants
are divided into 1 treatment group

Sponsors and collaborators