[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-lymphocytic-acute-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-lymphocytic-acute-adult":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"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":20,"type":21},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.",[25],"Leukemia, Lymphocytic, Acute, Adult",[27,28,29,30],"blinatumomab","newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia","induction treatment","reduced-dose chemotherapy","NOT_YET_RECRUITING","2024-10-17",{"date":34,"type":35},"2024-10-18","ACTUAL",{"date":37,"type":21},"2024-11-01",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Shandong University","OTHER"]