Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma

Sponsor
Ruijin Hospital
Study ID
NCT07405255
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib + Rituximab + MTX ± Selinexor — DRUG
    This is a single-arm interventional study. Participants will undergo an induction phase consisting of six 21-day cycles. During induction, all participants receive: Zanubrutinib 160 mg orally twice daily, Rituximab 375 mg/m² intravenous on Day 0, MTX 3.5 mg/m² intravenous on Days 1. Before the second treatment cycle, participants will be tested for TP53 mutation status. Participants who test positive for the TP53 mutation will receive Selinexor 40 mg orally on Days 1 weekly added to their treatment regimen. Following induction, participants enter a maintenance phase with: Zanubrutinib 160 mg orally twice daily, continued for up to 2 years or until disease progression or unacceptable toxicity. This design allows biomarker-driven treatment modification within a single treatment arm without randomization or separate comparator groups.

Study Details

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the mid-term or final assessment: If the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.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

Key Dates

Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
19 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm: Zanubrutinib + Rituximab + MTX ± Selinexor
    This single treatment arm includes an induction phase of six 21-day cycles where participants receive: Zanubrutinib 160 mg orally twice daily, Rituximab 375 mg/m² intravenously on Day 0, MTX 3.5 mg/m² intravenously on Days 1. Before starting the second cycle, TP53 mutation status will be assessed. Participants positive for TP53 mutation will have Selinexor 60 mg orally added on Days 1 and 3 weekly. Following induction, a maintenance phase consists of Zanubrutinib 160 mg orally twice daily for up to 2 years or until disease progression or unacceptable toxicity. This study uses a biomarker-driven approach within a single-arm design without randomization or comparator arms.

Primary Outcome Measure

Complete Remission Rate (CRR) [ Time Frame: At the end of Cycle 6 and at 4 weeks after completion of Cycle 6 (each cycle is 21 days). ]

Central Contacts

Related Studies