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.
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).
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.
Single group
Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)
Drug2 cycles of VPX regimen (21days per cycle) Teniposide: intravenous drip, 50mg d1-3; PD-1 monoclonal antibody: intravenous drip, 200mg d1; Selinixor: take 40mg orally, W1，60mg，W2，40mg biw，W3，cycle 1； 40mg， biw，cycle 2
Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning
Procedure/SurgeryTB preconditioning: Thiotepa intravenous drip 300mg/m2 d-6-d-5; Busulfan: intravenous drip, 0.8mg/kg q6h d-4--d2; followed by autologous peripheral stem cells infusion at day 0
Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)
Drug4 cycles of VPX regimen (21days per cycle) Teniposide: intravenous drip, 50mg d1-3; PD-1 monoclonal antibody: intravenous drip, 200mg d1; Selinixor: take 40mg orally biw, cycle 3-6；
Consolidation therapy-whole brain radiation therapy
Radiationwhole brain radiotherapy: CTV1: 20-30Gy/10fractions GTVp: 25-40Gy/10fractions
Maintenance treatment-PD-1 monoclonal antibody
DrugPD-1 monoclonal antibody for up to 2 years intravenous infusion, 200mg d1 (21days per cycle)
Overall response rate(ORR)
The rate of patients who achieved CR or PR after induction therapy with 2 cycles of VPX regimen
2-year progression-free survival(PFS)
PFS will be assessed from the first day of treatment to date of progression, relapse, death or end of follow-up.
Major adverse events
The safety and tolerability of the VPX regimen measured by the major adverse events.
Click on the lead sponsor to view all of their trials.
