About this trial
This study aims to evaluate the efficacy and safety of the VPX regimen, a novel combination of teniposide, PD-1 monoclonal antibody and selinexor, in patients with relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL) who have progressed after high-dose methotrexate (HD-MTX)-based systemic therapy. By investigating this therapeutic approach, we seek to establish a new treatment paradigm that may improve clinical outcomes of this high-risk population.
Eligibility criteria
Qualifiers
Age between 18 and 75 years old (inclusive).
Participants must be able to understand and willing to sign a written informed consent form.
The Eastern Cooperative Oncology Group is in a state of 0 to 3.
The expected lifespan is ≥ 3 months (according to researchers).
Disqualifiers
Chemotherapy, radiotherapy, immunotherapy, or antibody therapy for anti-tumor treatment, or herbal medicine with anti-tumor indications, small molecule targeted therapy within 2 weeks, monoclonal antibody conjugate drug or cytotoxic therapy within 10 weeks.
Participate in another clinical study using the research product within 4 weeks prior to the first day of treatment.
Patients who have used systemic corticosteroids for more than 5 days within 14 days prior to medication or require daily administration of>10mg dexamethasone or equivalent medication to control central nervous system disorders.
Active concurrent malignant tumors that require active treatment.
Trial design
Treatments tested in this trial
- Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)
- Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning
- Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)
- Consolidation therapy-whole brain radiation therapy
- Maintenance treatment-PD-1 monoclonal antibody