[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565995":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":10,"responsibleParty":34,"collaborators":37,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":10,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":100,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":10},{"fullName":5,"class":6},"Shandong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced-dose chemotherapy followed by blinatumomab induction treatment group",null,"Patients aged 15-65 with newly diagnosed Ph-negative B-ALL undergoing frontline induction therapy with reduced-dose chemotherapy followed by blinatumomab.",[13],"Drug: Blinatumomab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Blinatumomab","The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.",[9],[21,22],"Combination chemotherapy with multiple drugs.","preventive intrathecal injections",[24],{"name":25,"affiliation":26,"role":27},"Chunyan Ji, Doctor","Qilu Hospital of Shandong University","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Yanping Sun","CONTACT","18560089133","syp215920@163.com",{"type":27,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":26,"oldNameTitle":10,"oldOrganization":10},"Chunyan Ji","Prof.",[38,41,43,45,48,50,52,54,56,58,60,62,64,66,68,70,72,74,76],{"name":39,"class":40},"Shandong Provincial Hospital","OTHER_GOV",{"name":42,"class":6},"The Affiliated Hospital of Qingdao University",{"name":44,"class":6},"Tangshan Central Hospital",{"name":46,"class":47},"Affiliated Central Hospital of Shandong First Medical University","UNKNOWN",{"name":49,"class":6},"Yantai Yuhuangding Hospital",{"name":51,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":53,"class":6},"Qingdao Central Hospital",{"name":55,"class":6},"Qingdao Municipal Hospital",{"name":57,"class":6},"Affiliated Hospital of Jining Medical University",{"name":59,"class":47},"Affiliated Hospital of Binzhou Medical College",{"name":61,"class":6},"Linyi People's Hospital",{"name":63,"class":6},"The Second Hospital of Shandong University",{"name":65,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine",{"name":67,"class":6},"Shandong First Medical University",{"name":69,"class":6},"Shengli Oilfield Hospital",{"name":71,"class":6},"Heze Municipal Hospital",{"name":73,"class":40},"Zibo Central Hospital",{"name":75,"class":6},"Zaozhuang Municipal Hospital",{"name":77,"class":6},"Weihai Municipal Hospital","100565995","reduced-dose-chemo-followed-by-14-days-of-blinatumomab-for-newly-diagnosed-adult-b-all-patients-a-multicenter-study-100565995",false,"NCT06649422","Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study","Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.","Inclusion Criteria:\n\n* Age 15-65 years, both male and female are eligible;\n* Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing \\>20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and\u002For fluorescence in situ hybridization (FISH) BCR\u002FABL negative and\u002For molecular BCR\u002FABL fusion gene negative;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;\n* Organ function tests must meet all the following criteria: Total bilirubin \\\u003C1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\\u003C2.5×ULN (if liver is involved, then ALT and AST \\\u003C5×ULN are allowed); Creatinine \\\u003C1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.\n* Cardiac color Doppler echocardiography ejection fraction ≥45%;\n* Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).\n\nExclusion Criteria:\n\n* Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;\n* Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;\n* Patients participating in other clinical studies simultaneously;\n* Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;\n* A history of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Major surgery within the last 4 weeks or not recovered from previous surgery;\n* Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention;\n* Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women;\n* Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.);\n* Confirmed positive status for human immunodeficiency;\n* Active severe infections that cannot be controlled by oral or intravenous antibiotics;\n* Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and\u002For excipients);\n* Existence of bleeding disorders unrelated to ALL.","ALL","15 Years","65 Years",{"count":89,"type":90},36,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.",[94],"Leukemia, Lymphocytic, Acute, Adult",[96,97,98,99],"blinatumomab","newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia","induction treatment","reduced-dose chemotherapy","NOT_YET_RECRUITING","2024-10-17",{"date":103,"type":104},"2024-10-18","ACTUAL",{"date":106,"type":90},"2024-11-01",{"date":108,"type":90},"2027-12",{"name":5,"class":6}]