Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Soochow University

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

Treatment groups

40 Participants
are divided into 2 treatment groups