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

NCT07074470 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)

Interventions

DRUG

Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)

2 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

PROCEDURE

Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning

TB 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

DRUG

Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)

4 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；

RADIATION

Consolidation therapy-whole brain radiation therapy

whole brain radiotherapy: CTV1: 20-30Gy/10fractions GTVp: 25-40Gy/10fractions

DRUG

Maintenance treatment-PD-1 monoclonal antibody

PD-1 monoclonal antibody for up to 2 years intravenous infusion, 200mg d1 (21days per cycle)

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2030-01-02
Completion
2032-01-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074470 on ClinicalTrials.gov