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Primary Central Nervous System Lymphoma (PCNSL)VPXNCT07074470

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

A study testing Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor), Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning and Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor) in people with Primary Central Nervous System Lymphoma (PCNSL), run by The First Affiliated Hospital of Soochow University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor), Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning and Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
2 Jan 2025to 2 Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Primary central nervous system lymphoma of B-cell origin confirmed by pathology (histology or cytology).
  • Measurable diseases are defined as having a short diameter of at least 1.0cm through enhanced MRI.
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  • Recurrent/refractory PCNSL: Must have received at least one systemic treatment based on high-dose methotrexate.
  • 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).
  • 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/L, platelets ≥ 80 × 10 ^ 9/L, hemoglobin ≥ 80 g/L; Liver function: serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN, if there is liver metastasis); Glutamate oxalate transaminase (AST) and glutamate pyruvate transaminase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN, if there is liver metastasis); Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance rate ≥ 60 mL/min (male: Cr (ml/min)=(140 years old) × body weight (kg)/72 × serum creatinine concentration (mg/dl); Female: Cr (ml/min)=(140 years old) x body weight (kg)/85 x serum creatinine concentration (mg/dl)
  • Women with reproductive potential must agree to use efficient contraceptive methods during treatment and within 6 months after the last study drug administration. Sexually active males must agree to use highly effective contraceptive measures during treatment and within 6 months after the last dose of medication.
  • Can accept multiple MRI/CT and lumbar puncture examinations.
  • Swallowing oral tablets/capsules is not difficult.
  • Good compliance, willing to follow inspection procedures such as visit schedule, medication schedule, laboratory tests, etc.

Who cannot join

  • 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.
  • Patients who have received previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, selenidazole, and tiniposide drugs within 6 months prior to initial administration.
  • Suffering from uncontrolled or severe cardiovascular disease, including (but not limited to): any of the following: congestive heart failure (NYHA class III or IV); miocardial infarction; Unstable angina pectoris; Or there may be arrhythmia requiring treatment during screening, and the left ventricular ejection fraction (LVEF) within 6 months prior to initial administration is less than 50%; Primary cardiomyopathy (e.g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); A clinically significant medical history of QTc prolongation, grade II type II atrioventricular block or grade III atrioventricular block, or QTc interval (Method F)>470 milliseconds (females) or>480 milliseconds (males); Atrial fibrillation (EHRA ≥ 2b); Uncontrollable hypertensive patients are considered unsuitable to participate in this study.
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  • Uncontrolled infections or infections requiring intravenous antibiotic treatment.
  • Chronic hepatitis B carriers with active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ detection limit of each center; hepatitis C: HCV RNA positive) or syphilis. Attention: Non active carriers of HBV surface antigen (HBsAg), active HBV infection and persistent anti HBV suppression (HBV DNA<detection limit per center) subjects, as well as HCV cured subjects, can be recruited.
  • Human immunodeficiency virus (HIV) infection
  • Clinically significant gastrointestinal abnormalities that may affect drug intake, transportation, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery.
  • Previous allogeneic stem cell transplantation. Or those who have the intention of allogeneic hematopoietic stem cell transplantation;
  • For female participants, they are currently pregnant or breastfeeding.
  • Allergic to research drugs or excipients.
  • The patient has active mental illness, alcohol, drug or substance abuse.
  • There are any life-threatening diseases, medical conditions, or organ system dysfunction that researchers believe may affect patient safety or compliance with research procedures.
  • There are other researchers who believe that it is not suitable to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhengming Jin contact

67781856

jinzhengming519519@163.com

Changju Qu contact

67781856

qcj310@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Zhengming Jin, 67781856, jinzhengming519519@163.com

    Changju Qu, 67781856, qcj310@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Read the detailed description

This study will enroll patients aged 18-75 years with R/R PCNSL who have progressed after HD-MTX-based systemic therapy. Eligible participants will receive induction therapy with 2 cycles of VPX regimen followed by evaluation of contrast-enhanced magnetic resonance imaging (MRI) of the brain. Patients who got disease progression of stable disease will be withdrawn from this study. Patients who achieved partial remission(PR) or complete remission（CR）will receive consolidation treatment stratification as followings:

Group A (ASCT-eligible): Patients will proceed to autologous stem cell transplantation (ASCT) as consolidation therapy.

Group B (ASCT-ineligible): Patients will receive four additional cycles of VPX regimen, followed by whole-brain radiotherapy (WBRT) consolidation.

After consolidation therapy, all responders will receive PD-1 monoclonal antibody therapy maintenance for up to 2 years, or until disease progression or unacceptable toxicity occurs.

Being tested
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
Keywords
VPX, PCNSL, teniposide, PD-1, selinexor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

  • Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioningProcedure or surgery

    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

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

    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；

  • Consolidation therapy-whole brain radiation therapyRadiation

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

  • Maintenance treatment-PD-1 monoclonal antibodyDrug

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

Study groups in NCT07074470
Study groupRoleWhat they receive
Cohort 1 (ASCT-eligible)ExperimentalPatients achieving response after 2 cycles of VPX regimen will proceed to ASCT as consolidation therapy followed by PD-1 monoclonal antibody therapy maintenance for up to 2 years, or until disease progression or unacceptable toxicity occurs.
Receives: Drug: Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor); Procedure: Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning; Drug: Maintenance treatment-PD-1 monoclonal antibody
Cohort 2 (ASCT-ineligible)ExperimentalPatients achieving response after 2 cycles of VPX regimen will receive four additional cycles of VPX regimen, followed by whole-brain radiotherapy (WBRT) consolidation. After consolidation therapy, patients will receive PD-1 monoclonal antibody maintenance therapy for up to 2 years, or until disease progression or unacceptable toxicity occurs.
Receives: Drug: Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor); Drug: Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor); Radiation: Consolidation therapy-whole brain radiation therapy; Drug: Maintenance treatment-PD-1 monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate(ORR)

    The rate of patients who achieved CR or PR after induction therapy with 2 cycles of VPX regimen

    Measured: At the end of 2 cycles of VPX regimen (each cycle is 21 days)

Secondary outcomes (2)

  1. 2-year progression-free survival(PFS)

    PFS will be assessed from the first day of treatment to date of progression, relapse, death or end of follow-up.

    Measured: From enrollment to 2-year after the end of last patient's treatment

  2. Major adverse events

    The safety and tolerability of the VPX regimen measured by the major adverse events.

    Measured: From enrollment to 1 month after induction therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start2 Jan 2025
  3. Primary completion2 Jan 2030 (estimated)
  4. Study completion2 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074470
Sponsor's protocol ID
2024474
Acronym
VPX
Status last verified
Jul 2025
First submitted
9 Jul 2025
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kasamon YL, Price LSL, Okusanya OO, Richardson NC, Li RJ, Ma L, Wu YT, Theoret M, Pazdur R, Gormley NJ. FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Oncologist. 2021 Oct;26(10):879-886. doi: 10.1002/onco.13859. Epub 2021 Jul 1.

    PubMed 34132444

  • Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.

    PubMed 35834762

Questions about this trial

What is this clinical trial studying?

A study testing Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor), Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning and Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor) in people with Primary Central Nervous System Lymphoma (PCNSL), run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhengming Jin (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate(ORR) (time frame: At the end of 2 cycles of VPX regimen (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074470, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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