Actively Recruiting
Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-20
40
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old (inclusive)
- Able and willing to sign informed consent
- Eastern Cooperative Oncology Group performance status between 0 and 3
- Expected lifespan of at least 3 months
- Pathologically confirmed B-cell primary central nervous system lymphoma
- Measurable disease with lesion at least 1.0 cm in short diameter on MRI
- Relapsed or refractory PCNSL after at least one high-dose methotrexate-based systemic treatment
- Recovery from previous non-hematological treatment toxicities to grade 1 or normal (except hair loss)
- Adequate bone marrow, liver, coagulation, and kidney function within 14 days before screening without supportive medications
- Women of childbearing potential and sexually active men agree to use effective contraception during treatment and for 6 months after last dose
- Able to undergo multiple MRI/CT scans and lumbar punctures
- Able to swallow oral tablets or capsules
- Good compliance with study procedures and schedules
You will not qualify if you...
- Anti-tumor chemotherapy, radiotherapy, immunotherapy, herbal anti-tumor treatment, or targeted therapy within 2 weeks; monoclonal antibody conjugate or cytotoxic therapy within 10 weeks
- Participation in another clinical trial with the study drug within 4 weeks before treatment
- Systemic corticosteroid use >5 days within 14 days before treatment or daily dexamethasone >10 mg required
- Active concurrent cancers needing treatment
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, selenidazole, or teniposide within 6 months
- Uncontrolled or severe cardiovascular disease including heart failure, recent heart attack, unstable angina, significant arrhythmias, or low heart function
- Uncontrolled infections or infections needing IV antibiotics
- Active hepatitis B or C infection or syphilis; HIV infection
- Significant gastrointestinal issues affecting drug absorption or major gastric surgery
- Prior allogeneic stem cell transplant or planned for it
- Pregnant or breastfeeding women
- Allergy to study drugs or their components
- Active mental illness, substance abuse
- Life-threatening diseases or organ dysfunction affecting safety or study compliance
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Z
Zhengming Jin
CONTACT
C
Changju Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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