[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545040":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":71,"collaborators":51,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":51,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":51,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":56,"whyStopped":51,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment arm","EXPERIMENTAL","Linperlisib:\n\nPhase Ib：oral, 80 mg\u002Fd, QD; Phase II： oral, RP2D, QD.\n\nCamrelizumab for Injection:\n\nPhase Ib \\& Phase II：intravenous drip, 200 mg\u002Fd, Q3W, administered on day 1 of each cycle (3 weeks in each cycle)\n\nPegaspargase:\n\nPhase Ib \\& Phase II：intramuscular injection，2500 IU\u002Fm2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle)",[13,14,15,16],"Drug: Linperlisib","Drug: Camrelizumab","Drug: Pegaspargase","Drug: Dexamethasone",[18,25,31,37],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Linperlisib","Linperlisib: Phase Ib, oral, 80 mg\u002Fd, QD; Phase II, oral, RP2D, QD.",[9],[24],"YY-20394",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Camrelizumab","Camrelizumab for Injection: 200 mg\u002Fd, intravenous drip for 30 min (not less than 20 min and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing may be administered up to 5 days before or after the day of the scheduled dosing; more than 3 days after the date of the scheduled dosing will be considered a delayed dosing.",[9],[30],"Camrelizumab for Injection",{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Pegaspargase","Pegaspargase: 2500 IU\u002Fm2, intramuscular injection, divided into three places, administered on the first day of each cycle, observed 2 hours after injection for the occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving other test drugs. Every 3 weeks as a dosing cycle.\n\nCamrelizumab for Injection should not be applied on the same day as Dexamethasonee.",[9],[36],"Pegaspargase injection",{"type":19,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Dexamethasone","Dexamethasone, 20 mg\u002Fd, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.",[9],[42],"Dexamethasone oral",[44],{"name":45,"affiliation":5,"role":46},"Liang Wang, M.D.","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","+861058268442",null,"wangliangtrhos@126.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":51,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Liang Wang","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":62,"coordinates":63},"Point",[64,65],116.39723,39.9075,{"lat":65,"lon":64},[68,70],{"name":45,"role":49,"phone":69,"phoneExt":51,"email":52},"+8615001108693",{"name":45,"role":46,"phone":51,"phoneExt":51,"email":51},{"type":46,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"LIANG WANG","Director of the department of hematology","100545040","phase-1-linperlisib-combined-with-camrelizumab-and-pegaspargase-in-advanced-or-relapsedrefractory-nkt-cell-lymphoma-100545040",false,"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.","ALL","18 Years","75 Years",{"count":85,"type":86},43,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","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.",[93,94],"Natural Killer\u002FT-Cell Lymphoma, Nasal and Nasal-Type","T-lymphoblastic Lymphoma",[96,20,97,32],"r\u002Fr ENKTL","PD-1 blockade","2024-04-17",{"date":100,"type":101},"2024-04-19","ACTUAL",{"date":103,"type":101},"2024-04-14",{"date":105,"type":86},"2027-10-31",{"name":5,"class":6},1]