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New treatment option for Relapsed/Refractory Primary Central Nervous System Lymphoma
Official title A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT06556199
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, being studied as a potential treatment for relapsed/refractory primary central nervous system lymphoma.
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 is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles.
- Phase 2: a mid-size study of how well it works
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
- Aged between 18 and 75 (inclusive).
- Participants must be able to understand and be willing to sign a written informed consent document.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
- Primary central nervous system lymphoma (PCNSL) of B-cell origin confirmed by pathology (histology or cytology)
You likely can't join if
- Pathological diagnosis was T cell lymphoma.
- Anti-tumor therapy with chemotherapy, radiotherapy, immunotherapy or antibody drugs, or Chinese herbal medicine with anti-tumor indications...
- Participation in another clinical study with an investigational product during the 4 weeks prior to the first day of study treatment.
- Patients who use systemic adrenal corticosteroids for more than 5 days within 14 days prior to medication or who need to take \>10mg of dexamethasone...
- Active concurrent malignancy requiring active therapy.
- Prior treatment with temozolomide or anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs within 6 months prior to initial administration
See the full eligibility criteria
- Aged between 18 and 75 (inclusive).
- Participants must be able to understand and be willing to sign a written informed consent document.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
- Primary central nervous system lymphoma (PCNSL) of B-cell origin confirmed by pathology (histology or cytology)
- Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.
- Recurrent/refractory PCNSL: Must have received at least one systemic treatment with methotrexate-based treatment.
- Any non-hematological toxicity associated with previous treatment should return to grade 1 or normal (except hair loss according to NCI CTCAE version 5.0)
- Bone marrow and organ function meet the following criteria (no blood transfusion within 14 days prior to screening, no G-CSF, no medication correction) :
- 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); Glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN, if there is liver...
- Coagulation function: International standardized ratio (INR) and activated partial thrombin time ≤1.5×ULN;
- Renal function: serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min (male: Cr (ml/min) = (140-age) × body weight (kg) /72× serum creatinine concentration (mg/dl); Female: Cr (ml/min) = (140- age) ×...
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to...
- Can accept multiple MRI/CT and lumbar puncture examination.
- Swallowing oral tablets/capsules without difficulty.
- Good compliance, willing to follow the visit schedule, dosing schedule, laboratory examination and other test procedure.
- Pathological diagnosis was T cell lymphoma.
- Anti-tumor therapy with chemotherapy, radiotherapy, immunotherapy or antibody drugs, or Chinese herbal medicine with anti-tumor indications, small-molecule targeted therapy within 2 weeks, monoclonal antibody-coupled...
- Participation in another clinical study with an investigational product during the 4 weeks prior to the first day of study treatment.
- Patients who use systemic adrenal corticosteroids for more than 5 days within 14 days prior to medication or who need to take \>10mg of dexamethasone or equivalent drugs daily to control CNS disease.
- Active concurrent malignancy requiring active therapy.
- Prior treatment with temozolomide or anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs within 6 months prior to initial administration
- Have uncontrolled or significant cardiovascular disease, including (but not limited to) : Any of the following: congestive heart failure (NYHA Class III or IV);myocardial infarction; unstable angina; or the presence of...
- Uncontrolled infections or infections that require 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≥ the detection limit of each center; Hepatitis C: HCV RNA...
- Human immunodeficiency virus (HIV) infection
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total...
- Prior allogenic stem cell transplant.
- For female people, they are currently pregnant or breastfeeding.
- Allergy to the investigational drug or excipient.
- The patient has active mental illness, alcohol, drug or substance abuse.
- The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the patient's safety or compliance with the study procedure.
- There are other conditions that the investigator considers inappropriate to participate in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, Zhejiang, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Hanzhou, Zhejiang, 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.