[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558828":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":30,"locations":40,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"selinexor-based treatment","EXPERIMENTAL",null,[13,14,15],"Drug: Selinexor","Drug: Temozolomide","Drug: Anti-PD-1 monoclonal antibody",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Selinexor","Selinexor dose escalation: 40,60,80mg respectively every week, and dose expansion at the RP2D of Selinexor,every 3 weeks for 6 cycles.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"Temozolomide","Temozolomide 150mg\u002Fm2 po d1-5 every 3 weeks for 6 cycles.",[9],{"type":18,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Anti-PD-1 monoclonal antibody","The dose of anti-PD-1 monoclonal antibody is fixed dose 200 mg intravenously every 3 weeks until until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Xianggui Yuan","CONTACT","+8613989883884","yuanxg@zju.edu.cn",{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},"Wenbin Qian","+8613605801032","qianwb@zju.edu.cn",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":11,"geoPoint":11,"contacts":49},"2nd Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hanzhou","Zhejiang","310009","China","CN",[50],{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100558828","phase-1-a-study-of-selinexor-in-combination-with-temozolomide-and-anti-pd-1-antibody-in-patients-with-relapsedrefractory-primary-central-nervous-system-lymphoma-100558828",false,"NCT06556199","A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","The Efficiency and Safety of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma: A Prospective, Single-arm, Open, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Aged between 18 and 75 (inclusive).\n* Participants must be able to understand and be willing to sign a written informed consent document.\n* Eastern Cooperative Oncology Group performance status 0 to 3.\n* Life expectancy of ≥ 3 months (in the opinion of the investigator).\n* Primary central nervous system lymphoma (PCNSL) of B-cell origin confirmed by pathology (histology or cytology)\n* Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.\n* Recurrent\u002Frefractory PCNSL: Must have received at least one systemic treatment with methotrexate-based treatment.\n* 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)\n* Bone marrow and organ function meet the following criteria (no blood transfusion within 14 days prior to screening, no G-CSF, no medication correction) :\n\n  1. Bone marrow function: absolute value of neutrophils ≥1.5×10\\^9\u002FL, platelets ≥80×10\\^9\u002FL, hemoglobin ≥80 g\u002FL;\n  2. 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 metastasis);\n  3. Coagulation function: International standardized ratio (INR) and activated partial thrombin time ≤1.5×ULN;\n  4. Renal function: serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin (male: Cr (ml\u002Fmin) = (140-age) × body weight (kg) \u002F72× serum creatinine concentration (mg\u002Fdl); Female: Cr (ml\u002Fmin) = (140- age) × body weight (kg) \u002F85× serum creatinine concentration (mg\u002Fdl)\n* 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 use highly effective contraception during the period of therapy and for 6 months after the last dose.\n* Can accept multiple MRI\u002FCT and lumbar puncture examination.\n* Swallowing oral tablets\u002Fcapsules without difficulty.\n* Good compliance, willing to follow the visit schedule, dosing schedule, laboratory examination and other test procedure.\n\nExclusion Criteria:\n\n* Pathological diagnosis was T cell lymphoma.\n* 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 drugs or cytotoxin therapy within 10 weeks, and autologous stem cell transplantation within 6 months before the first administration.\n* Participation in another clinical study with an investigational product during the 4 weeks prior to the first day of study treatment.\n* 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.\n* Active concurrent malignancy requiring active therapy.\n* Prior treatment with temozolomide or anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs within 6 months prior to initial administration\n* 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 an arrhythmia requiring treatment at the time of screening with a left ventricular ejection fraction (LVEF) \\\u003C 50% in the 6 months prior to initial dosing; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block, or QTc interphase (method F) \\> 470 msec (female) or \\> 480msec (male);Atrial fibrillation (EHRA grade ≥2b);Patients with unmanageable hypertension were deemed unsuitable for participation in the study.\n* Uncontrolled infections or infections that require intravenous antibiotic treatment.\n* 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 positive) or syphilis. Notes: Non-active HBV surface antigen (HBsAg) carriers, subjects with active HBV infection and persistent anti-HBV inhibition (HBV DNA \\\u003C each center detection limit), and subjects cured of HCV can be enrolled.\n* Human immunodeficiency virus (HIV) infection\n* Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery.\n* Prior allogenic stem cell transplant.\n* For female subjects, they are currently pregnant or breastfeeding.\n* Allergy to the investigational drug or excipient.\n* The patient has active mental illness, alcohol, drug or substance abuse.\n* 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.\n* There are other conditions that the investigator considers inappropriate to participate in this clinical trial.","ALL","18 Years","75 Years",{"count":64,"type":65},38,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","This study is a prospective, single-arm, open label, Phase Ib\u002FII clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed\u002Frefractory 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 II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).",[72],"Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","2025-07-28",{"date":75,"type":76},"2025-07-31","ACTUAL",{"date":78,"type":76},"2024-08-31",{"date":80,"type":65},"2028-08-31",{"name":5,"class":6},1]