[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"natural-killert-cell-lymphoma-nasal-and-nasal-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:natural-killert-cell-lymphoma-nasal-and-nasal-type":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100560894","phase-2-sintilimab-with-p-gemox-versus-the-p-gemox-in-the-teatment-of-advanced-stage-extranodal-natural-killert-cell-lymphoma-100560894",false,"NCT06583083","Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer\u002FT Cell Lymphoma","A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer\u002FT Cell Lymphoma (ENKTL) (SPIRIT-02)","SPIRIT-02","Inclusion Criteria:\n\n1. Pathologically diagnosed with ENKTL.\n2. Advanced stage.\n3. Has at least one measurable or assessable lesion.\n4. Age \\> 18 years, no gender restrictions, with an expected survival of more than 3 months.\n5. Willing to participate in the clinical study; fully informed and has signed a written informed consent form.\n6. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Aggressive NK-cell leukemia.\n2. Central nervous system involvement.\n3. Patients with significant dysfunction of vital organs.\n4. History of allergy to the investigational drug, similar drugs, or excipients.\n5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).\n6. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.\n7. Active infection, excluding fever related to tumor-associated B symptoms.\n8. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS).","ALL","18 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Extranodal NK\u002FT-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1\u002FPD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK\u002FT-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK\u002FT-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK\u002FT-cell lymphoma patients.",[27],"Natural Killer\u002FT-Cell Lymphoma, Nasal and Nasal-Type","RECRUITING","2026-04-09",{"date":31,"type":32},"2026-04-14","ACTUAL",{"date":34,"type":32},"2024-10-22",{"date":36,"type":21},"2026-08-28",{"name":38,"class":39},"Sun Yat-sen University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100540245","phase-2-screening-study-of-combined-sequential-chemotherapy-and-radiation-therapy-for-early-stage-nkt-cell-lymphoma-100540245","NCT06314334","Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK\u002FT-cell Lymphoma","A Multicenter, Randomized, Controlled Phase II Screening Study of Combined Sequential Chemotherapy and Radiation Therapies for Early-stage Natural Killer\u002FT-cell Lymphoma (IE\u002FIIE)","Inclusion Criteria:\n\n* Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination.\n* Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE\u002FIIE based on PET\u002FCT and bone marrow examination according to the Lugano 2014 criteria.\n* Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET\u002FCT.\n* No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma.\n* Age between 18 and 75 years, both genders.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2.\n* Must have adequate organ and bone marrow function, defined as follows:\n\nHematology: Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL, platelet count (PLT) ≥75×10\\^9\u002FL, hemoglobin (Hb) ≥90g\u002FL; no administration of granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion in the previous 14 days.\n\nLiver function: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN.\n\nRenal function: Serum creatinine (Cr) ≤1.5×ULN. Coagulation function: Plasma fibrinogen ≥1.5g\u002FL. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no acute myocardial infarction, arrhythmia, or atrioventricular conduction block of grade I or above on electrocardiogram.\n\n* Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations.\n\nExclusion Criteria:\n\n* Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA \\>10\\^3\u002Fml.\n* Patients with a history of pancreatitis.\n* Patients with acute or systemic infections requiring intravenous antibiotic therapy.\n* Patients with severe complications such as hemophagocytic syndrome, DIC, etc.\n* Significant organ dysfunction: such as respiratory failure, chronic congestive heart failure with NYHA class ≥2, decompensated liver or renal dysfunction, uncontrolled hypertension and diabetes despite aggressive treatment, and cardiovascular thrombotic or hemorrhagic events in the past 6 months.\n* Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors.\n* Pregnant and lactating women.\n* Patients with psychiatric disorders.\n* Known allergies to drugs in the chemotherapy regimen.\n* Patients with concomitant other tumors requiring surgery or chemotherapy within the past 6 months.\n* Currently using other experimental drugs.","75 Years",{"count":50,"type":21},210,[24],"Extranodal NK\u002FT-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.",[27],[55,56,57,58],"Chemotherapy","Radiation therapy","Immune checkpoint inhibitor","Pegaspargase","2026-04-03",{"date":29,"type":32},{"date":62,"type":32},"2024-03-04",{"date":64,"type":21},"2028-12-30",{"name":66,"class":39},"Fudan University",7,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":40},"100545040","phase-1-linperlisib-combined-with-camrelizumab-and-pegaspargase-in-advanced-or-relapsedrefractory-nkt-cell-lymphoma-100545040","NCT06376721","Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed\u002FRefractory NK\u002FT-cell Lymphoma","A Phase Ib\u002FII Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed\u002FRefractory NK\u002FT-cell Lymphoma","Inclusion Criteria:\n\n* Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.\n* refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients\n* PET\u002FCT or CT\u002FMRI with at least one objectively evaluable lesion.\n* Expected to survive more than 3 months.\n* General status ECOG score 0-2 points.\n* The laboratory test within 1 week before enrollment meets the following conditions:\n\nBlood routine: WBC≥3×10e9\u002FL, PLT≥75×10e9\u002FL, ANC≥1.5×10e9\u002FL. sCR≤1.5 mg\u002FdL,GFR≥50 ml\u002Fmin. Liver function: ALT \\& AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.\n\nSerum fibrinogen level≥1.0 g\u002FL.\n\n•Sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with CNS involvement, or with other neoplasm;\n* Patients has received PI3K inhibitor treatment before enrollment\n* Poor performance status, ECOG≥2;\n* Patients in lactation or pregnancy；\n* Patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures；\n* Patients allergic to any of the study drugs；\n* Patients with active infection；\n* Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n* Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia;\n* Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past\n* According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.",{"count":76,"type":21},43,[78,24],"PHASE1","The patients diagnosed with relapsed\u002Frefractory or advanced NK\u002FT-cell Lymphoma (r\u002Fr NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r\u002Fr NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.",[27,81],"T-lymphoblastic Lymphoma",[83,84,85,58],"r\u002Fr ENKTL","Linperlisib","PD-1 blockade","2024-04-17",{"date":88,"type":32},"2024-04-19",{"date":90,"type":32},"2024-04-14",{"date":92,"type":21},"2027-10-31",{"name":94,"class":39},"Beijing Tongren Hospital"]