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New treatment option for Primary Central Nervous System Lymphoma (PCNSL)
Official title Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL
ClinicalTrials.gov ID: NCT07074470
What this study is testing
What is Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)?
Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma (pcnsl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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).
You likely can't join if
- Chemotherapy, radiotherapy, immunotherapy, or antibody therapy for anti-tumor treatment, or herbal medicine with anti-tumor indications, small...
- 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...
- 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...
- Suffering from uncontrolled or severe cardiovascular disease, including (but not limited to): any of the following: congestive heart failure (NYHA...
See the full eligibility criteria
- 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.
- 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 \^...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transportation, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.