[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521872":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":40,"collaborators":19,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":19,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":19,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"blinatumomab","EXPERIMENTAL","Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug\u002Fday, continuous intravenous drip for 24 hours, day 3-7: 16ug\u002Fday, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.",[13],"Drug: blinatumomab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The dose of one course was as follows: day 1-2: 8ug\u002Fday, continuous intravenous drip for 24 hours, day 3-7: 16ug\u002Fday, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Jie Ji, MD","CONTACT","86-28-85422373","jieji@scu.edu.cn",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"West China Hospital of Sichuan University","Chengdu","Sichuan","610044","China","CN",{"type":35,"coordinates":36},"Point",[37,38],104.06667,30.66667,{"lat":38,"lon":37},{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jie Ji","Principle Investigator","100521872","phase-2-blinatumomab-prevents-recurrence-of-rr-all-after-allo-hsct-100521872",false,"NCT06075238","Blinatumomab Prevents Recurrence of R\u002FR ALL After Allo-HSCT","Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;\n2. Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);\n3. KPS \\> 60 or ECOG 0-2;\n4. The expected survival time is more than 3 months;\n5. Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;\n6. Reach the standard of hematopoietic reconstitution (neutrophil count\n\n   ≥ 0.5×10\\^9\u002FL for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\\^9\u002FL for 7 consecutive days without platelet transfusion, Hb ≥ 80 g \u002FL without red blood cell transfusion); and neutrophil count ≥ 1.5×10\\^9\u002FL, platelet count ≥ 50×10\\^9\u002FL within 45 days after transplantation;\n7. No central nervous system involvement or clinical symptoms after transplantation;\n8. Those who have no serious functional damage to important organs of the body;\n9. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;\n10. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;\n2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;\n3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;\n4. Poor graft function (PGF) occurred after allo-HSCT;\n5. Combined with other malignant tumors and require treatment;\n6. Active GVHD;\n7. Have a history of allergy to Chidamide;\n8. Pregnant or lactating females;\n9. Patients with known history of human immunodeficiency virus (HIV) virus infection and\u002For acquired immunodeficiency syndrome;\n10. Patients with active chronic hepatitis B or active hepatitis C;\n11. History of prolonged QT syndrome;\n12. Patients considered by other researchers to be unsuitable for this study","ALL","16 Years","65 Years",{"count":55,"type":56},68,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","The goal of this phase I\u002FII clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R\u002FR ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:\n\n• The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R\u002FR ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug\u002Fday, continuous intravenous drip for 24 hours, day 3-7: 16ug\u002Fday, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.",[62],"Leukemia, Lymphoid","NOT_YET_RECRUITING","2023-10-03",{"date":66,"type":67},"2023-10-10","ACTUAL",{"date":69,"type":56},"2023-10-01",{"date":71,"type":56},"2026-09-30",{"name":5,"class":6},1]