RecruitingNot ApplicableNCT07074470

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

A Prospective Study of Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed and Refractory Primary Central Nervous System Lymphoma.


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

40 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of three drugs — teniposide (chemotherapy), a PD-1 immune checkpoint blocker, and selinexor (a targeted drug) — for people with primary central nervous system lymphoma (brain lymphoma) that has come back or not responded to prior treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed B-cell lymphoma in the brain or spinal fluid (primary CNS lymphoma) - Your cancer has come back or not responded to at least one prior treatment that included high-dose methotrexate - You have measurable disease visible on MRI scan - Your life expectancy is at least 3 months - Your blood counts and organ function are at acceptable levels **You may NOT be eligible if...** - You have significant ongoing side effects from previous treatments - Your overall health or organ function is too poor for the study - You are outside the 18–75 age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInduction 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

PROCEDUREConsolidation 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

DRUGConsolidation 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;

RADIATIONConsolidation therapy-whole brain radiation therapy

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

DRUGMaintenance treatment-PD-1 monoclonal antibody

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


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07074470


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