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Recruiting NCT07074470

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

Trial Parameters

Condition Primary Central Nervous System Lymphoma (PCNSL)
Sponsor The First Affiliated Hospital of Soochow University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-01-02
Completion 2030-01-02
Interventions
Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioningConsolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)

Brief 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 Criteria

Inclusion Criteria: 1. Age between 18 and 75 years old (inclusive). 2. Participants must be able to understand and willing to sign a written informed consent form. 3. The Eastern Cooperative Oncology Group is in a state of 0 to 3. 4. The expected lifespan is ≥ 3 months (according to researchers). 5. Primary central nervous system lymphoma of B-cell origin confirmed by pathology (histology or cytology). 6. Measurable diseases are defined as having a short diameter of at least 1.0cm through enhanced MRI. 7. Recurrent/refractory PCNSL: Must have received at least one systemic treatment based on high-dose methotrexate. 8. Any non hematological toxicity related to previous treatment should be restored to grade 1 or normal (excluding hair loss according to NCI CTCAE 5.0). 9. Bone marrow and organ function meet the following criteria (no blood transfusion, no G-CSF, no medication correction within 14 days prior to screening): Bone marrow function: absolute value of neutrophils ≥ 1.5 × 10 \^ 9

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